Trial Outcomes & Findings for Safety, Tolerability, Pharmacokinetics (PK), and Food Effect of MK-7762 in Healthy Adults (NCT NCT05824091)
NCT ID: NCT05824091
Last Updated: 2026-06-04
Results Overview
Blood samples were collected for the analysis of Serum coagulation parameters: PT, PTT, and INR.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
119 participants
Primary outcome timeframe
Up to Day 36
Results posted on
2026-06-04
Participant Flow
This was a first-in-human trial of MK-7762, administered orally to healthy adults. It was a randomized, placebo-controlled, two-part trial. Part 1 consisted of double-blind single ascending dose (SAD) Cohorts 1 to 5, and food effect (FE) Cohort 6 (open-label). Part 2 consisted of a FE cohort 7 (open-label) and three sequential double-blind multiple ascending dose (MAD) cohorts (Cohorts 8 to 10).
A total of 119 participants (including 2 replacement participants in Part 2) were dosed (48 in Part 1 and 71 in Part 2), and a total of 97 participants were exposed to MK-7762 (38 from Part 1 and 59 from Part 2).
Participant milestones
| Measure |
Part 1: Cohort 1: SAD MK-7762 50 Milligrams (mg) Fasted
Participants were randomized to receive a single dose of MK-7762 50 mg.
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Part 1: Cohort 2: SAD MK-7762 150 mg Fasted
Participants were randomized to receive a single dose of MK-7762 150 mg.
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Part 1: Cohort 3: SAD MK-7762 300 mg Fasted
Participants were randomized to receive a single dose of MK-7762 300 mg.
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Part 1: Cohort 4: SAD MK-7762 600 mg Fasted
Participants were randomized to receive a single dose of MK-7762 600 mg.
|
Part 1: Cohort 5: SAD MK-7762 1200 mg Fasted
Participants were randomized to receive a single dose of MK-7762 1200 mg.
|
Part 1: Placebo (Pooled)
Participants were randomized to receive a single dose of placebo in capsule sizes matching MK-7762 10 mg, 100 mg, and/or 300 mg.
|
Part 1: Cohort 6: FE MK-7762 300 mg, Sequence: Fasted/Fed
Participants were administered a single dose of MK-7762 in an open-label, cross-over design (fasted followed by fed condition) to evaluate the effect of food on pharmacokinetics (PK). Each treatment sequence was separated by a washout period of 8 Days.
|
Part 1: Cohort 6: FE MK-7762 300 mg, Sequence: Fed/Fasted
Participants were administered a single dose of MK-7762 in an open-label, cross-over design (fed followed by fasted condition) to evaluate the effect of food on PK. Each treatment sequence was separated by a washout period of 8 Days.
|
Part 2: Cohort 7: FE 600 mg MK-7762, Sequence: Fasted/Standard/High-Fat
The FE Cohort 7 was an open-label, 3-period evaluation of 600 mg MK-7762 in the fasted state, followed by treatment in a fed state with standard meal breakfast, followed by treatment in a fed state with high-fat meal breakfast. Treatment periods in the sequence were separated by a washout period of 8 days.
|
Part 2: Cohort 7: FE 600 mg MK-7762 Sequence: Standard/High-Fat/Fasted
The FE Cohort 7 was an open-label, 3-period evaluation of 600 mg MK-7762 in a fed state with a standard meal breakfast, followed by treatment in a fed state with a high-fat meal breakfast, followed by treatment in a fasted state. Treatment periods in the sequence were separated by a washout period of 8 days.
|
Part 2: Cohort 7: FE 600 mg MK-7762 Sequence: High-Fat/Fasted/Standard
The FE Cohort 7 was an open-label, 3-period evaluation of 600 mg MK-7762 in a fed state with a high-fat meal breakfast, followed by treatment in a fasted state, followed by treatment in a fed state with a standard meal breakfast. Treatment periods in the sequence were separated by a washout period of 8 days.
|
Part 2: Cohort 8: MAD MK-7762 100 mg Fasted
Participants were randomized to receive MK-7762 100 mg in fasted state.
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Part 2: Cohort 9: MAD MK-7762 300 mg Fasted
Participants were randomized to receive MK-7762 300 mg in fasted state.
|
Part 2: Cohort 10: MAD MK-7762 500 mg Fasted
Participants were randomized to receive MK-7762 500 mg in fasted state.
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Part 2: Cohort 8: MAD MK-7762 100 mg Fed
Participants were randomized to receive MK-7762 100 mg in fed state with a standard meal breakfast.
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Part 2: Cohort 9: MAD MK-7762 300 mg Fed
Participants were randomized to receive MK-7762 300 mg in fed state with a standard meal breakfast.
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Part 2: Cohort 10: MAD MK-7762 500 mg Fed
Participants were randomized to receive MK-7762 500 mg in fed state with a standard meal breakfast.
|
Part 2: Placebo (Pooled)
Participants were randomized to receive placebo in fasted state or in fed state with standard breakfast meal in capsule sizes matching MK-7762 100 mg and/or 300 mg.
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Part 1: SAD Cohorts (Up to Day 7)
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Part 1: SAD Cohorts (Up to Day 7)
COMPLETED
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Part 1: SAD Cohorts (Up to Day 7)
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Part1: Period 1 FE Cohort 6(Up to Day 7)
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Part1: Period 1 FE Cohort 6(Up to Day 7)
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Part1: Period 1 FE Cohort 6(Up to Day 7)
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Part1: Washout Period (8 Days)
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Part1: Washout Period (8 Days)
COMPLETED
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Part1: Washout Period (8 Days)
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Part1: Period 2 FE Cohort 6(Up to Day 7)
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Part1: Period 2 FE Cohort 6(Up to Day 7)
COMPLETED
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Part1: Period 2 FE Cohort 6(Up to Day 7)
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Part 2:Period 1 FE Cohort 7(Up to Day 8)
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Part 2:Period 1 FE Cohort 7(Up to Day 8)
COMPLETED
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Part 2:Period 1 FE Cohort 7(Up to Day 8)
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Part2: Washout Period ( 8 Days)
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Part2: Washout Period ( 8 Days)
COMPLETED
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Part2: Washout Period ( 8 Days)
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Part 2:Period 2 FE Cohort 7(Up to Day 8)
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Part 2:Period 2 FE Cohort 7(Up to Day 8)
COMPLETED
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Part 2:Period 2 FE Cohort 7(Up to Day 8)
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Part2: Washout Period (8 Days)
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Part2: Washout Period (8 Days)
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Part 2:Period 3 FE Cohort 7(Up to Day 8)
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Part 2:Period 3 FE Cohort 7(Up to Day 8)
COMPLETED
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Part 2:Period 3 FE Cohort 7(Up to Day 8)
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Part 2: MAD Cohorts (Up to Day 36)
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8
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12
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Part 2: MAD Cohorts (Up to Day 36)
COMPLETED
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Part 2: MAD Cohorts (Up to Day 36)
NOT COMPLETED
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Reasons for withdrawal
| Measure |
Part 1: Cohort 1: SAD MK-7762 50 Milligrams (mg) Fasted
Participants were randomized to receive a single dose of MK-7762 50 mg.
|
Part 1: Cohort 2: SAD MK-7762 150 mg Fasted
Participants were randomized to receive a single dose of MK-7762 150 mg.
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Part 1: Cohort 3: SAD MK-7762 300 mg Fasted
Participants were randomized to receive a single dose of MK-7762 300 mg.
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Part 1: Cohort 4: SAD MK-7762 600 mg Fasted
Participants were randomized to receive a single dose of MK-7762 600 mg.
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Part 1: Cohort 5: SAD MK-7762 1200 mg Fasted
Participants were randomized to receive a single dose of MK-7762 1200 mg.
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Part 1: Placebo (Pooled)
Participants were randomized to receive a single dose of placebo in capsule sizes matching MK-7762 10 mg, 100 mg, and/or 300 mg.
|
Part 1: Cohort 6: FE MK-7762 300 mg, Sequence: Fasted/Fed
Participants were administered a single dose of MK-7762 in an open-label, cross-over design (fasted followed by fed condition) to evaluate the effect of food on pharmacokinetics (PK). Each treatment sequence was separated by a washout period of 8 Days.
|
Part 1: Cohort 6: FE MK-7762 300 mg, Sequence: Fed/Fasted
Participants were administered a single dose of MK-7762 in an open-label, cross-over design (fed followed by fasted condition) to evaluate the effect of food on PK. Each treatment sequence was separated by a washout period of 8 Days.
|
Part 2: Cohort 7: FE 600 mg MK-7762, Sequence: Fasted/Standard/High-Fat
The FE Cohort 7 was an open-label, 3-period evaluation of 600 mg MK-7762 in the fasted state, followed by treatment in a fed state with standard meal breakfast, followed by treatment in a fed state with high-fat meal breakfast. Treatment periods in the sequence were separated by a washout period of 8 days.
|
Part 2: Cohort 7: FE 600 mg MK-7762 Sequence: Standard/High-Fat/Fasted
The FE Cohort 7 was an open-label, 3-period evaluation of 600 mg MK-7762 in a fed state with a standard meal breakfast, followed by treatment in a fed state with a high-fat meal breakfast, followed by treatment in a fasted state. Treatment periods in the sequence were separated by a washout period of 8 days.
|
Part 2: Cohort 7: FE 600 mg MK-7762 Sequence: High-Fat/Fasted/Standard
The FE Cohort 7 was an open-label, 3-period evaluation of 600 mg MK-7762 in a fed state with a high-fat meal breakfast, followed by treatment in a fasted state, followed by treatment in a fed state with a standard meal breakfast. Treatment periods in the sequence were separated by a washout period of 8 days.
|
Part 2: Cohort 8: MAD MK-7762 100 mg Fasted
Participants were randomized to receive MK-7762 100 mg in fasted state.
|
Part 2: Cohort 9: MAD MK-7762 300 mg Fasted
Participants were randomized to receive MK-7762 300 mg in fasted state.
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Part 2: Cohort 10: MAD MK-7762 500 mg Fasted
Participants were randomized to receive MK-7762 500 mg in fasted state.
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Part 2: Cohort 8: MAD MK-7762 100 mg Fed
Participants were randomized to receive MK-7762 100 mg in fed state with a standard meal breakfast.
|
Part 2: Cohort 9: MAD MK-7762 300 mg Fed
Participants were randomized to receive MK-7762 300 mg in fed state with a standard meal breakfast.
|
Part 2: Cohort 10: MAD MK-7762 500 mg Fed
Participants were randomized to receive MK-7762 500 mg in fed state with a standard meal breakfast.
|
Part 2: Placebo (Pooled)
Participants were randomized to receive placebo in fasted state or in fed state with standard breakfast meal in capsule sizes matching MK-7762 100 mg and/or 300 mg.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Part 2:Period 1 FE Cohort 7(Up to Day 8)
Adverse Event
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0
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Part 2: MAD Cohorts (Up to Day 36)
Adverse Event
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Baseline Characteristics
Safety, Tolerability, Pharmacokinetics (PK), and Food Effect of MK-7762 in Healthy Adults
Baseline characteristics by cohort
| Measure |
Part 1: Cohort 1: SAD MK-7762 50 Milligrams (mg) Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 50 mg.
|
Part 1: Cohort 2: SAD MK-7762 150 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 150 mg.
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Part 1: Cohort 3: SAD MK-7762 300 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 300 mg.
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Part 1: Cohort 4: SAD MK-7762 600 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 600 mg.
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Part 1: Cohort 5: SAD MK-7762 1200 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 1200 mg.
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Part 1: Placebo (Pooled)
n=10 Participants
Participants were randomized to receive a single dose of placebo in capsule sizes matching MK-7762 10 mg, 100 mg, and/or 300 mg.
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Part 1: Cohort 6: FE MK-7762 300 mg, Sequence: Fasted/Fed
n=3 Participants
Participants were administered a single dose of MK-7762 in an open-label, cross-over design (fasted followed by fed condition) to evaluate the effect of food on pharmacokinetics (PK). Each treatment sequence was separated by a washout period of 8 Days.
|
Part 1: Cohort 6: FE MK-7762 300 mg, Sequence: Fed/Fasted
n=5 Participants
Participants were administered a single dose of MK-7762 in an open-label, cross-over design (fed followed by fasted condition) to evaluate the effect of food on PK. Each treatment sequence was separated by a washout period of 8 Days.
|
Part 2: Cohort 7: FE 600 mg MK-7762, Sequence: Fasted/Standard/High-Fat
n=4 Participants
The FE Cohort 7 was an open-label, 3-period evaluation of 600 mg MK-7762 in the fasted state, followed by treatment in a fed state with standard meal breakfast, followed by treatment in a fed state with high-fat meal breakfast. Treatment periods in the sequence were separated by a washout period of 8 days.
|
Part 2: Cohort 7: FE 600 mg MK-7762 Sequence: Standard/High-Fat/Fasted
n=4 Participants
The FE Cohort 7 was an open-label, 3-period evaluation of 600 mg MK-7762 in a fed state with a standard meal breakfast, followed by treatment in a fed state with a high-fat meal breakfast, followed by treatment in a fasted state. Treatment periods in the sequence were separated by a washout period of 8 days.
|
Part 2: Cohort 7: FE 600 mg MK-7762 Sequence: High-Fat/Fasted/Standard
n=3 Participants
The FE Cohort 7 was an open-label, 3-period evaluation of 600 mg MK-7762 in a fed state with a high-fat meal breakfast, followed by treatment in a fasted state, followed by treatment in a fed state with a standard meal breakfast. Treatment periods in the sequence were separated by a washout period of 8 days.
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Part 2: Cohort 8: MAD MK-7762 100 mg Fasted
n=8 Participants
Participants were randomized to receive MK-7762 100 mg in fasted state.
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Part 2: Cohort 9: MAD MK-7762 300 mg Fasted
n=8 Participants
Participants were randomized to receive MK-7762 300 mg in fasted state.
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Part 2: Cohort 10: MAD MK-7762 500 mg Fasted
n=8 Participants
Participants were randomized to receive MK-7762 500 mg in fasted state.
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Part 2: Cohort 8: MAD MK-7762 100 mg Fed
n=8 Participants
Participants were randomized to receive MK-7762 100 mg in fed state with a standard meal breakfast.
|
Part 2: Cohort 9: MAD MK-7762 300 mg Fed
n=8 Participants
Participants were randomized to receive MK-7762 300 mg in fed state with a standard meal breakfast.
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Part 2: Cohort 10: MAD MK-7762 500 mg Fed
n=8 Participants
Participants were randomized to receive MK-7762 500 mg in fed state with a standard meal breakfast.
|
Part 2: Placebo (Pooled)
n=12 Participants
Participants were randomized to receive placebo in fasted state or in fed state with standard breakfast meal in capsule sizes matching MK-7762 100 mg and/or 300 mg.
|
Total
n=119 Participants
Total of all reporting groups
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Age, Continuous
|
33.3 Years
STANDARD_DEVIATION 6.9 • n=9 Participants
|
35.0 Years
STANDARD_DEVIATION 9.3 • n=27 Participants
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42.0 Years
STANDARD_DEVIATION 11.8 • n=267 Participants
|
41.5 Years
STANDARD_DEVIATION 10.6 • n=265 Participants
|
40.2 Years
STANDARD_DEVIATION 6.4 • n=568 Participants
|
30.9 Years
STANDARD_DEVIATION 9.0 • n=22 Participants
|
40.0 Years
STANDARD_DEVIATION 9.2 • n=23 Participants
|
34.4 Years
STANDARD_DEVIATION 10.4 • n=22 Participants
|
34.5 Years
STANDARD_DEVIATION 6.1 • n=178 Participants
|
43.3 Years
STANDARD_DEVIATION 2.8 • n=116 Participants
|
36.7 Years
STANDARD_DEVIATION 7.5 • n=2 Participants
|
32.3 Years
STANDARD_DEVIATION 7.61 • n=4 Participants
|
39.9 Years
STANDARD_DEVIATION 10.2 • n=190 Participants
|
38.3 Years
STANDARD_DEVIATION 7.15 • n=19 Participants
|
38.9 Years
STANDARD_DEVIATION 7.12 • n=18 Participants
|
40.9 Years
STANDARD_DEVIATION 10.1 • n=18 Participants
|
41.5 Years
STANDARD_DEVIATION 6.80 • n=14 Participants
|
41.0 Years
STANDARD_DEVIATION 7.0 • n=16 Participants
|
37.9 Years
STANDARD_DEVIATION 8.1 • n=17 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
1 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=178 Participants
|
1 Participants
n=116 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=190 Participants
|
1 Participants
n=19 Participants
|
2 Participants
n=18 Participants
|
1 Participants
n=18 Participants
|
2 Participants
n=14 Participants
|
2 Participants
n=16 Participants
|
15 Participants
n=17 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=9 Participants
|
6 Participants
n=27 Participants
|
4 Participants
n=267 Participants
|
5 Participants
n=265 Participants
|
5 Participants
n=568 Participants
|
10 Participants
n=22 Participants
|
3 Participants
n=23 Participants
|
5 Participants
n=22 Participants
|
4 Participants
n=178 Participants
|
3 Participants
n=116 Participants
|
3 Participants
n=2 Participants
|
7 Participants
n=4 Participants
|
8 Participants
n=190 Participants
|
7 Participants
n=19 Participants
|
6 Participants
n=18 Participants
|
7 Participants
n=18 Participants
|
6 Participants
n=14 Participants
|
10 Participants
n=16 Participants
|
104 Participants
n=17 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
1 Participants
n=568 Participants
|
1 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
1 Participants
n=22 Participants
|
1 Participants
n=178 Participants
|
1 Participants
n=116 Participants
|
0 Participants
n=2 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=190 Participants
|
2 Participants
n=19 Participants
|
1 Participants
n=18 Participants
|
1 Participants
n=18 Participants
|
2 Participants
n=14 Participants
|
6 Participants
n=16 Participants
|
25 Participants
n=17 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=9 Participants
|
6 Participants
n=27 Participants
|
4 Participants
n=267 Participants
|
5 Participants
n=265 Participants
|
5 Participants
n=568 Participants
|
9 Participants
n=22 Participants
|
3 Participants
n=23 Participants
|
4 Participants
n=22 Participants
|
3 Participants
n=178 Participants
|
3 Participants
n=116 Participants
|
3 Participants
n=2 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=190 Participants
|
6 Participants
n=19 Participants
|
7 Participants
n=18 Participants
|
7 Participants
n=18 Participants
|
6 Participants
n=14 Participants
|
6 Participants
n=16 Participants
|
94 Participants
n=17 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=178 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=190 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=17 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=178 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=190 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=17 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=178 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=190 Participants
|
1 Participants
n=19 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=14 Participants
|
1 Participants
n=16 Participants
|
3 Participants
n=17 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=178 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=190 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=16 Participants
|
1 Participants
n=17 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
2 Participants
n=265 Participants
|
4 Participants
n=568 Participants
|
5 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
1 Participants
n=22 Participants
|
2 Participants
n=178 Participants
|
1 Participants
n=116 Participants
|
1 Participants
n=2 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=190 Participants
|
2 Participants
n=19 Participants
|
4 Participants
n=18 Participants
|
2 Participants
n=18 Participants
|
2 Participants
n=14 Participants
|
3 Participants
n=16 Participants
|
41 Participants
n=17 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=9 Participants
|
4 Participants
n=27 Participants
|
5 Participants
n=267 Participants
|
4 Participants
n=265 Participants
|
2 Participants
n=568 Participants
|
5 Participants
n=22 Participants
|
3 Participants
n=23 Participants
|
3 Participants
n=22 Participants
|
1 Participants
n=178 Participants
|
3 Participants
n=116 Participants
|
2 Participants
n=2 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=190 Participants
|
5 Participants
n=19 Participants
|
4 Participants
n=18 Participants
|
6 Participants
n=18 Participants
|
5 Participants
n=14 Participants
|
8 Participants
n=16 Participants
|
70 Participants
n=17 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
1 Participants
n=22 Participants
|
1 Participants
n=178 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=190 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
1 Participants
n=14 Participants
|
0 Participants
n=16 Participants
|
4 Participants
n=17 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=178 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=190 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=17 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 7Population: Safety Population.
An AE is any untoward medical occurrence in a clinical study participant whether or not considered related to the study intervention. A TEAE is any AE that occurs after receipt of one or more doses of study drug through the end of study for that participant. A SAE is defined as any untoward medical occurrence that, at any dose: results in death or is life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization or results in persistent disability/incapacity or is a congenital anomaly/birth defect or is a medically significant / important event or reaction. AESIs are adverse events that the Sponsor monitored carefully and were subject to expedited reporting to the Sponsor.
Outcome measures
| Measure |
Part 2: Placebo (Pooled)
n=6 Participants
Participants were randomized to receive placebo in fasted state or in fed state with standard breakfast meal in capsule sizes matching MK-7762 100 mg and/or 300 mg.
|
Part 1: Cohort 1: SAD MK-7762 50 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 50 mg.
|
Part 1: Cohort 2: SAD MK-7762 150 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 150 mg.
|
Part 1: Cohort 3: SAD MK-7762 300 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 300 mg.
|
Part 1: Cohort 5: SAD MK-7762 1200 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 1200 mg.
|
Part 1: Placebo (Pooled)
n=10 Participants
Participants were randomized to receive a single dose of placebo in capsule sizes matching MK-7762 10 mg, 100 mg, and/or 300 mg.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fasted
n=8 Participants
Participants were administered a single dose of MK-7762 300 mg in fasted condition.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fed
n=8 Participants
Participants were administered a single dose of MK-7762 300 mg in fed condition.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Percentage of Participants Reporting Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs)
Any SAE
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Part 1: Percentage of Participants Reporting Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs)
Any TEAE
|
17 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
17 Percentage of participants
|
17 Percentage of participants
|
20 Percentage of participants
|
0 Percentage of participants
|
13 Percentage of participants
|
|
Part 1: Percentage of Participants Reporting Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs)
Any AESI
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 7Population: Safety Population.
An AE is any untoward medical occurrence in a clinical study participant whether or not considered related to the study intervention. A TEAE is any AE that occurs after receipt of one or more doses of study drug through the end of study for that participant. The intensity for each AE reported during the study were assigned to 1 of 5 categories: Grade 1 Mild symptoms, causing no or minimal interference with usual social and functional activities with intervention not indicated; Grade 2 Moderate symptoms, causing greater than minimal interference with usual social and functional activities with intervention indicated; Grade 3 Severe symptoms, causing inability to perform usual social and functional activities with intervention or hospitalization indicated; Grade 4 Potentially life-threatening symptoms, causing inability to perform basic self-care functions with intervention indicated to prevent permanent impairment, persistent disability, or death and Grade 5: Fatal.
Outcome measures
| Measure |
Part 2: Placebo (Pooled)
n=6 Participants
Participants were randomized to receive placebo in fasted state or in fed state with standard breakfast meal in capsule sizes matching MK-7762 100 mg and/or 300 mg.
|
Part 1: Cohort 1: SAD MK-7762 50 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 50 mg.
|
Part 1: Cohort 2: SAD MK-7762 150 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 150 mg.
|
Part 1: Cohort 3: SAD MK-7762 300 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 300 mg.
|
Part 1: Cohort 5: SAD MK-7762 1200 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 1200 mg.
|
Part 1: Placebo (Pooled)
n=10 Participants
Participants were randomized to receive a single dose of placebo in capsule sizes matching MK-7762 10 mg, 100 mg, and/or 300 mg.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fasted
n=8 Participants
Participants were administered a single dose of MK-7762 300 mg in fasted condition.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fed
n=8 Participants
Participants were administered a single dose of MK-7762 300 mg in fed condition.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Percentage of Participants Reporting TEAEs by Severity
Moderate
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
17 Percentage of participants
|
10 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Part 1: Percentage of Participants Reporting TEAEs by Severity
Severe
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Part 1: Percentage of Participants Reporting TEAEs by Severity
Mild
|
17 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
17 Percentage of participants
|
0 Percentage of participants
|
10 Percentage of participants
|
0 Percentage of participants
|
13 Percentage of participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 7Population: Safety Population.
An AE is any untoward medical occurrence in a clinical study participant whether or not considered related to the study intervention. A TEAE is any AE that occurs after receipt of one or more doses of study drug through the end of study for that participant.
Outcome measures
| Measure |
Part 2: Placebo (Pooled)
n=6 Participants
Participants were randomized to receive placebo in fasted state or in fed state with standard breakfast meal in capsule sizes matching MK-7762 100 mg and/or 300 mg.
|
Part 1: Cohort 1: SAD MK-7762 50 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 50 mg.
|
Part 1: Cohort 2: SAD MK-7762 150 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 150 mg.
|
Part 1: Cohort 3: SAD MK-7762 300 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 300 mg.
|
Part 1: Cohort 5: SAD MK-7762 1200 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 1200 mg.
|
Part 1: Placebo (Pooled)
n=10 Participants
Participants were randomized to receive a single dose of placebo in capsule sizes matching MK-7762 10 mg, 100 mg, and/or 300 mg.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fasted
n=8 Participants
Participants were administered a single dose of MK-7762 300 mg in fasted condition.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fed
n=8 Participants
Participants were administered a single dose of MK-7762 300 mg in fed condition.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Percentage of Participants Reporting Study Drug Related TEAEs
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
17 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
13 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to Day 7Population: Safety Population.
An AE is any untoward medical occurrence in a clinical study participant whether or not considered related to the study intervention. A TEAE is any AE that occurs after receipt of one or more doses of study drug through the end of study for that participant. A SAE is defined as any untoward medical occurrence that, at any dose: results in death or is life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization or results in persistent disability/incapacity or is a congenital anomaly/birth defect or is a medically significant / important event or reaction. AESIs are adverse events that the Sponsor monitored carefully and were subject to expedited reporting to the Sponsor.
Outcome measures
| Measure |
Part 2: Placebo (Pooled)
Participants were randomized to receive placebo in fasted state or in fed state with standard breakfast meal in capsule sizes matching MK-7762 100 mg and/or 300 mg.
|
Part 1: Cohort 1: SAD MK-7762 50 mg Fasted
n=10 Participants
Participants were randomized to receive a single dose of MK-7762 50 mg.
|
Part 1: Cohort 2: SAD MK-7762 150 mg Fasted
n=10 Participants
Participants were randomized to receive a single dose of MK-7762 150 mg.
|
Part 1: Cohort 3: SAD MK-7762 300 mg Fasted
n=9 Participants
Participants were randomized to receive a single dose of MK-7762 300 mg.
|
Part 1: Cohort 5: SAD MK-7762 1200 mg Fasted
Participants were randomized to receive a single dose of MK-7762 1200 mg.
|
Part 1: Placebo (Pooled)
Participants were randomized to receive a single dose of placebo in capsule sizes matching MK-7762 10 mg, 100 mg, and/or 300 mg.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fasted
Participants were administered a single dose of MK-7762 300 mg in fasted condition.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fed
Participants were administered a single dose of MK-7762 300 mg in fed condition.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: FE Cohort 7: Percentage of Participants Reporting TEAEs, SAEs, and AESIs
Any TEAE
|
—
|
50 Percentage of participants
|
40 Percentage of participants
|
56 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Part 2: FE Cohort 7: Percentage of Participants Reporting TEAEs, SAEs, and AESIs
Any SAE
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Part 2: FE Cohort 7: Percentage of Participants Reporting TEAEs, SAEs, and AESIs
Any AESI
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 7Population: Safety Population.
An AE is any untoward medical occurrence in a clinical study participant whether or not considered related to the study intervention. A TEAE is any AE that occurs after receipt of one or more doses of study drug through the end of study for that participant.
Outcome measures
| Measure |
Part 2: Placebo (Pooled)
Participants were randomized to receive placebo in fasted state or in fed state with standard breakfast meal in capsule sizes matching MK-7762 100 mg and/or 300 mg.
|
Part 1: Cohort 1: SAD MK-7762 50 mg Fasted
n=10 Participants
Participants were randomized to receive a single dose of MK-7762 50 mg.
|
Part 1: Cohort 2: SAD MK-7762 150 mg Fasted
n=10 Participants
Participants were randomized to receive a single dose of MK-7762 150 mg.
|
Part 1: Cohort 3: SAD MK-7762 300 mg Fasted
n=9 Participants
Participants were randomized to receive a single dose of MK-7762 300 mg.
|
Part 1: Cohort 5: SAD MK-7762 1200 mg Fasted
Participants were randomized to receive a single dose of MK-7762 1200 mg.
|
Part 1: Placebo (Pooled)
Participants were randomized to receive a single dose of placebo in capsule sizes matching MK-7762 10 mg, 100 mg, and/or 300 mg.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fasted
Participants were administered a single dose of MK-7762 300 mg in fasted condition.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fed
Participants were administered a single dose of MK-7762 300 mg in fed condition.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: FE Cohort 7: Percentage of Participants Reporting Study Drug Related TEAEs
|
—
|
10 Percentage of participants
|
20 Percentage of participants
|
11 Percentage of participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 7Population: Safety Population.
An AE is any untoward medical occurrence in a clinical study participant whether or not considered related to the study intervention. A TEAE is any AE that occurs after receipt of one or more doses of study drug through the end of study for that participant. The intensity for each AE reported during the study were assigned to 1 of 5 categories: Grade 1 Mild symptoms, causing no or minimal interference with usual social and functional activities with intervention not indicated; Grade 2 Moderate symptoms, causing greater than minimal interference with usual social and functional activities with intervention indicated; Grade 3 Severe symptoms, causing inability to perform usual social and functional activities with intervention or hospitalization indicated; Grade 4 Potentially life-threatening symptoms, causing inability to perform basic self-care functions with intervention indicated to prevent permanent impairment, persistent disability, or death and Grade 5: Fatal.
Outcome measures
| Measure |
Part 2: Placebo (Pooled)
Participants were randomized to receive placebo in fasted state or in fed state with standard breakfast meal in capsule sizes matching MK-7762 100 mg and/or 300 mg.
|
Part 1: Cohort 1: SAD MK-7762 50 mg Fasted
n=10 Participants
Participants were randomized to receive a single dose of MK-7762 50 mg.
|
Part 1: Cohort 2: SAD MK-7762 150 mg Fasted
n=10 Participants
Participants were randomized to receive a single dose of MK-7762 150 mg.
|
Part 1: Cohort 3: SAD MK-7762 300 mg Fasted
n=9 Participants
Participants were randomized to receive a single dose of MK-7762 300 mg.
|
Part 1: Cohort 5: SAD MK-7762 1200 mg Fasted
Participants were randomized to receive a single dose of MK-7762 1200 mg.
|
Part 1: Placebo (Pooled)
Participants were randomized to receive a single dose of placebo in capsule sizes matching MK-7762 10 mg, 100 mg, and/or 300 mg.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fasted
Participants were administered a single dose of MK-7762 300 mg in fasted condition.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fed
Participants were administered a single dose of MK-7762 300 mg in fed condition.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: FE Cohort 7: Percentage of Participants Reporting TEAEs by Severity
Mild
|
—
|
40 Percentage of participants
|
40 Percentage of participants
|
56 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Part 2: FE Cohort 7: Percentage of Participants Reporting TEAEs by Severity
Moderate
|
—
|
10 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Part 2: FE Cohort 7: Percentage of Participants Reporting TEAEs by Severity
Severe
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 through Day 36.Population: Safety Population. Data were collected across MAD cohorts based on dose levels, regardless of fasting status.
An AE is any untoward medical occurrence in a clinical study participant whether or not considered related to the study intervention. A TEAE is any AE that occurs after receipt of one or more doses of study drug through the end of study for that participant. A SAE is defined as any untoward medical occurrence that, at any dose: results in death or is life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization or results in persistent disability/incapacity or is a congenital anomaly/birth defect or is a medically significant / important event or reaction. AESIs are adverse events that the Sponsor monitored carefully and were subject to expedited reporting to the Sponsor.
Outcome measures
| Measure |
Part 2: Placebo (Pooled)
n=12 Participants
Participants were randomized to receive placebo in fasted state or in fed state with standard breakfast meal in capsule sizes matching MK-7762 100 mg and/or 300 mg.
|
Part 1: Cohort 1: SAD MK-7762 50 mg Fasted
n=16 Participants
Participants were randomized to receive a single dose of MK-7762 50 mg.
|
Part 1: Cohort 2: SAD MK-7762 150 mg Fasted
n=16 Participants
Participants were randomized to receive a single dose of MK-7762 150 mg.
|
Part 1: Cohort 3: SAD MK-7762 300 mg Fasted
n=16 Participants
Participants were randomized to receive a single dose of MK-7762 300 mg.
|
Part 1: Cohort 5: SAD MK-7762 1200 mg Fasted
Participants were randomized to receive a single dose of MK-7762 1200 mg.
|
Part 1: Placebo (Pooled)
Participants were randomized to receive a single dose of placebo in capsule sizes matching MK-7762 10 mg, 100 mg, and/or 300 mg.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fasted
Participants were administered a single dose of MK-7762 300 mg in fasted condition.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fed
Participants were administered a single dose of MK-7762 300 mg in fed condition.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: MAD Cohorts: Percentage of Participants Reporting TEAEs, SAEs, and AESIs
Any AESI
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Part 2: MAD Cohorts: Percentage of Participants Reporting TEAEs, SAEs, and AESIs
Any TEAE
|
67 Percentage of participants
|
75 Percentage of participants
|
63 Percentage of participants
|
88 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Part 2: MAD Cohorts: Percentage of Participants Reporting TEAEs, SAEs, and AESIs
Any SAE
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 through Day 36.Population: Safety Population. Data were collected across MAD cohorts based on dose levels, regardless of fasting status.
An AE is any untoward medical occurrence in a clinical study participant whether or not considered related to the study intervention. A TEAE is any AE that occurs after receipt of one or more doses of study drug through the end of study for that participant. The intensity for each AE reported during the study were assigned to 1 of 5 categories: Grade 1 Mild symptoms, causing no or minimal interference with usual social and functional activities with intervention not indicated; Grade 2 Moderate symptoms, causing greater than minimal interference with usual social and functional activities with intervention indicated; Grade 3 Severe symptoms, causing inability to perform usual social and functional activities with intervention or hospitalization indicated; Grade 4 Potentially life-threatening symptoms, causing inability to perform basic self-care functions with intervention indicated to prevent permanent impairment, persistent disability, or death and Grade 5: Fatal.
Outcome measures
| Measure |
Part 2: Placebo (Pooled)
n=12 Participants
Participants were randomized to receive placebo in fasted state or in fed state with standard breakfast meal in capsule sizes matching MK-7762 100 mg and/or 300 mg.
|
Part 1: Cohort 1: SAD MK-7762 50 mg Fasted
n=16 Participants
Participants were randomized to receive a single dose of MK-7762 50 mg.
|
Part 1: Cohort 2: SAD MK-7762 150 mg Fasted
n=16 Participants
Participants were randomized to receive a single dose of MK-7762 150 mg.
|
Part 1: Cohort 3: SAD MK-7762 300 mg Fasted
n=16 Participants
Participants were randomized to receive a single dose of MK-7762 300 mg.
|
Part 1: Cohort 5: SAD MK-7762 1200 mg Fasted
Participants were randomized to receive a single dose of MK-7762 1200 mg.
|
Part 1: Placebo (Pooled)
Participants were randomized to receive a single dose of placebo in capsule sizes matching MK-7762 10 mg, 100 mg, and/or 300 mg.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fasted
Participants were administered a single dose of MK-7762 300 mg in fasted condition.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fed
Participants were administered a single dose of MK-7762 300 mg in fed condition.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: MAD Cohorts: Percentage of Participants Reporting TEAEs by Severity
Mild
|
17 Percentage of participants
|
50 Percentage of participants
|
38 Percentage of participants
|
31 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Part 2: MAD Cohorts: Percentage of Participants Reporting TEAEs by Severity
Moderate
|
50 Percentage of participants
|
25 Percentage of participants
|
25 Percentage of participants
|
56 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Part 2: MAD Cohorts: Percentage of Participants Reporting TEAEs by Severity
Severe
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 through Day 36Population: Safety Population. Data were collected across MAD cohorts based on dose levels, regardless of fasting status.
An AE is any untoward medical occurrence in a clinical study participant whether or not considered related to the study intervention. A TEAE is any AE that occurs after receipt of one or more doses of study drug through the end of study for that participant.
Outcome measures
| Measure |
Part 2: Placebo (Pooled)
n=12 Participants
Participants were randomized to receive placebo in fasted state or in fed state with standard breakfast meal in capsule sizes matching MK-7762 100 mg and/or 300 mg.
|
Part 1: Cohort 1: SAD MK-7762 50 mg Fasted
n=16 Participants
Participants were randomized to receive a single dose of MK-7762 50 mg.
|
Part 1: Cohort 2: SAD MK-7762 150 mg Fasted
n=16 Participants
Participants were randomized to receive a single dose of MK-7762 150 mg.
|
Part 1: Cohort 3: SAD MK-7762 300 mg Fasted
n=16 Participants
Participants were randomized to receive a single dose of MK-7762 300 mg.
|
Part 1: Cohort 5: SAD MK-7762 1200 mg Fasted
Participants were randomized to receive a single dose of MK-7762 1200 mg.
|
Part 1: Placebo (Pooled)
Participants were randomized to receive a single dose of placebo in capsule sizes matching MK-7762 10 mg, 100 mg, and/or 300 mg.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fasted
Participants were administered a single dose of MK-7762 300 mg in fasted condition.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fed
Participants were administered a single dose of MK-7762 300 mg in fed condition.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: MAD Cohorts: Proportion of Participants Reporting Study Drug Related TEAEs
|
17 Percentage of participants
|
25 Percentage of participants
|
13 Percentage of participants
|
19 Percentage of participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 7Population: Safety Population.
Blood samples were collected for the analysis of hematology parameters: complete blood count (red blood cells, hemoglobin, platelets, and white blood cells \[WBC\]); red blood cell parameters (eg, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, and red cell distribution width); white blood cell differential (absolute counts), including neutrophils, lymphocytes, monocytes, eosinophils and basophils; and reticulocyte count
Outcome measures
| Measure |
Part 2: Placebo (Pooled)
n=6 Participants
Participants were randomized to receive placebo in fasted state or in fed state with standard breakfast meal in capsule sizes matching MK-7762 100 mg and/or 300 mg.
|
Part 1: Cohort 1: SAD MK-7762 50 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 50 mg.
|
Part 1: Cohort 2: SAD MK-7762 150 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 150 mg.
|
Part 1: Cohort 3: SAD MK-7762 300 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 300 mg.
|
Part 1: Cohort 5: SAD MK-7762 1200 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 1200 mg.
|
Part 1: Placebo (Pooled)
n=10 Participants
Participants were randomized to receive a single dose of placebo in capsule sizes matching MK-7762 10 mg, 100 mg, and/or 300 mg.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fasted
n=8 Participants
Participants were administered a single dose of MK-7762 300 mg in fasted condition.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fed
n=8 Participants
Participants were administered a single dose of MK-7762 300 mg in fed condition.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Clinically Significant Changes in Hematology Parameters
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Day 7Population: Safety Population.
Blood samples were collected for the analysis of chemistry parameters: alanine transaminase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), total and direct bilirubin, creatinine, blood urea nitrogen (BUN) or urea, creatine kinase, sodium, potassium, bicarbonate or CO2, chloride, glucose, and lipid profile (total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, and triglycerides.
Outcome measures
| Measure |
Part 2: Placebo (Pooled)
n=6 Participants
Participants were randomized to receive placebo in fasted state or in fed state with standard breakfast meal in capsule sizes matching MK-7762 100 mg and/or 300 mg.
|
Part 1: Cohort 1: SAD MK-7762 50 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 50 mg.
|
Part 1: Cohort 2: SAD MK-7762 150 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 150 mg.
|
Part 1: Cohort 3: SAD MK-7762 300 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 300 mg.
|
Part 1: Cohort 5: SAD MK-7762 1200 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 1200 mg.
|
Part 1: Placebo (Pooled)
n=10 Participants
Participants were randomized to receive a single dose of placebo in capsule sizes matching MK-7762 10 mg, 100 mg, and/or 300 mg.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fasted
n=8 Participants
Participants were administered a single dose of MK-7762 300 mg in fasted condition.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fed
n=8 Participants
Participants were administered a single dose of MK-7762 300 mg in fed condition.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Clinically Significant Changes in Chemistry Parameters
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Day 7Population: Safety Population.
Blood samples were collected for the analysis of Serum coagulation parameters: Prothrombin Time (PT), Partial Thromboplastin Time (PTT), and international normalized ratio (INR).
Outcome measures
| Measure |
Part 2: Placebo (Pooled)
n=6 Participants
Participants were randomized to receive placebo in fasted state or in fed state with standard breakfast meal in capsule sizes matching MK-7762 100 mg and/or 300 mg.
|
Part 1: Cohort 1: SAD MK-7762 50 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 50 mg.
|
Part 1: Cohort 2: SAD MK-7762 150 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 150 mg.
|
Part 1: Cohort 3: SAD MK-7762 300 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 300 mg.
|
Part 1: Cohort 5: SAD MK-7762 1200 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 1200 mg.
|
Part 1: Placebo (Pooled)
n=10 Participants
Participants were randomized to receive a single dose of placebo in capsule sizes matching MK-7762 10 mg, 100 mg, and/or 300 mg.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fasted
n=8 Participants
Participants were administered a single dose of MK-7762 300 mg in fasted condition.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fed
n=8 Participants
Participants were administered a single dose of MK-7762 300 mg in fed condition.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Clinically Significant Changes in Serum Coagulation Parameters
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Day 7Population: Safety Population.
Urine samples were collected for the analysis of urinalysis parameters: Dipstick for potential of hydrogen (pH), specific gravity, glucose, protein, blood, leukocyte esterase, nitrites, ketones, bilirubin, and urobilinogen. Microscopic examination for red blood cells, white blood cells, casts, and bacteria was performed if urine dipstick is positive for protein, blood, leukocyte esterase, or nitrites.
Outcome measures
| Measure |
Part 2: Placebo (Pooled)
n=6 Participants
Participants were randomized to receive placebo in fasted state or in fed state with standard breakfast meal in capsule sizes matching MK-7762 100 mg and/or 300 mg.
|
Part 1: Cohort 1: SAD MK-7762 50 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 50 mg.
|
Part 1: Cohort 2: SAD MK-7762 150 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 150 mg.
|
Part 1: Cohort 3: SAD MK-7762 300 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 300 mg.
|
Part 1: Cohort 5: SAD MK-7762 1200 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 1200 mg.
|
Part 1: Placebo (Pooled)
n=10 Participants
Participants were randomized to receive a single dose of placebo in capsule sizes matching MK-7762 10 mg, 100 mg, and/or 300 mg.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fasted
n=8 Participants
Participants were administered a single dose of MK-7762 300 mg in fasted condition.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fed
n=8 Participants
Participants were administered a single dose of MK-7762 300 mg in fed condition.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Clinically Significant Changes in Urinalysis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Day 7Population: Safety Population.
Vital parameters including temperature, heart rate (HR), and blood pressure (BP) were measured in supine position. Data for number of participants with abnormal clinically significant changes for vital signs have been presented.
Outcome measures
| Measure |
Part 2: Placebo (Pooled)
n=6 Participants
Participants were randomized to receive placebo in fasted state or in fed state with standard breakfast meal in capsule sizes matching MK-7762 100 mg and/or 300 mg.
|
Part 1: Cohort 1: SAD MK-7762 50 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 50 mg.
|
Part 1: Cohort 2: SAD MK-7762 150 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 150 mg.
|
Part 1: Cohort 3: SAD MK-7762 300 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 300 mg.
|
Part 1: Cohort 5: SAD MK-7762 1200 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 1200 mg.
|
Part 1: Placebo (Pooled)
n=10 Participants
Participants were randomized to receive a single dose of placebo in capsule sizes matching MK-7762 10 mg, 100 mg, and/or 300 mg.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fasted
n=8 Participants
Participants were administered a single dose of MK-7762 300 mg in fasted condition.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fed
n=8 Participants
Participants were administered a single dose of MK-7762 300 mg in fed condition.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Clinically Significant Changes in Vital Parameters
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Day 7Population: Safety Population.
ECG parameters included HR, RR interval, PR interval, QRS duration, QT interval, and QT interval corrected by Fridericia's formula (QTcF).
Outcome measures
| Measure |
Part 2: Placebo (Pooled)
n=6 Participants
Participants were randomized to receive placebo in fasted state or in fed state with standard breakfast meal in capsule sizes matching MK-7762 100 mg and/or 300 mg.
|
Part 1: Cohort 1: SAD MK-7762 50 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 50 mg.
|
Part 1: Cohort 2: SAD MK-7762 150 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 150 mg.
|
Part 1: Cohort 3: SAD MK-7762 300 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 300 mg.
|
Part 1: Cohort 5: SAD MK-7762 1200 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 1200 mg.
|
Part 1: Placebo (Pooled)
n=10 Participants
Participants were randomized to receive a single dose of placebo in capsule sizes matching MK-7762 10 mg, 100 mg, and/or 300 mg.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fasted
n=8 Participants
Participants were administered a single dose of MK-7762 300 mg in fasted condition.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fed
n=8 Participants
Participants were administered a single dose of MK-7762 300 mg in fed condition.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Day 8Population: Safety Population.
Blood samples were collected for the analysis of hematology parameters: complete blood count (red blood cells, hemoglobin, platelets, and WBC); red blood cell parameters (eg, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, and red cell distribution width); white blood cell differential (absolute counts), including neutrophils, lymphocytes, monocytes, eosinophils and basophils; and reticulocyte count.
Outcome measures
| Measure |
Part 2: Placebo (Pooled)
Participants were randomized to receive placebo in fasted state or in fed state with standard breakfast meal in capsule sizes matching MK-7762 100 mg and/or 300 mg.
|
Part 1: Cohort 1: SAD MK-7762 50 mg Fasted
n=10 Participants
Participants were randomized to receive a single dose of MK-7762 50 mg.
|
Part 1: Cohort 2: SAD MK-7762 150 mg Fasted
n=10 Participants
Participants were randomized to receive a single dose of MK-7762 150 mg.
|
Part 1: Cohort 3: SAD MK-7762 300 mg Fasted
n=9 Participants
Participants were randomized to receive a single dose of MK-7762 300 mg.
|
Part 1: Cohort 5: SAD MK-7762 1200 mg Fasted
Participants were randomized to receive a single dose of MK-7762 1200 mg.
|
Part 1: Placebo (Pooled)
Participants were randomized to receive a single dose of placebo in capsule sizes matching MK-7762 10 mg, 100 mg, and/or 300 mg.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fasted
Participants were administered a single dose of MK-7762 300 mg in fasted condition.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fed
Participants were administered a single dose of MK-7762 300 mg in fed condition.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: FE Cohort 7: Number of Participants With Clinically Significant Changes in Hematology Parameters
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 36Population: Safety Population. Data were collected across MAD cohorts based on dose levels, regardless of fasting status.
Blood samples were collected for the analysis of hematology parameters: complete blood count (red blood cells, hemoglobin, platelets, and WBC); red blood cell parameters (eg, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, and red cell distribution width); white blood cell differential (absolute counts), including neutrophils, lymphocytes, monocytes, eosinophils and basophils; and reticulocyte count
Outcome measures
| Measure |
Part 2: Placebo (Pooled)
n=12 Participants
Participants were randomized to receive placebo in fasted state or in fed state with standard breakfast meal in capsule sizes matching MK-7762 100 mg and/or 300 mg.
|
Part 1: Cohort 1: SAD MK-7762 50 mg Fasted
n=16 Participants
Participants were randomized to receive a single dose of MK-7762 50 mg.
|
Part 1: Cohort 2: SAD MK-7762 150 mg Fasted
n=16 Participants
Participants were randomized to receive a single dose of MK-7762 150 mg.
|
Part 1: Cohort 3: SAD MK-7762 300 mg Fasted
n=16 Participants
Participants were randomized to receive a single dose of MK-7762 300 mg.
|
Part 1: Cohort 5: SAD MK-7762 1200 mg Fasted
Participants were randomized to receive a single dose of MK-7762 1200 mg.
|
Part 1: Placebo (Pooled)
Participants were randomized to receive a single dose of placebo in capsule sizes matching MK-7762 10 mg, 100 mg, and/or 300 mg.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fasted
Participants were administered a single dose of MK-7762 300 mg in fasted condition.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fed
Participants were administered a single dose of MK-7762 300 mg in fed condition.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: MAD Cohorts: Number of Participants With Clinically Significant Changes in Hematology Parameters
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 8Population: Safety Population.
Blood samples were collected for the analysis of chemistry parameters: ALT, AST, ALP, total and direct bilirubin, creatinine, BUN or urea, creatine kinase, sodium, potassium, bicarbonate or CO2, chloride, glucose, and lipid profile (total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides).
Outcome measures
| Measure |
Part 2: Placebo (Pooled)
Participants were randomized to receive placebo in fasted state or in fed state with standard breakfast meal in capsule sizes matching MK-7762 100 mg and/or 300 mg.
|
Part 1: Cohort 1: SAD MK-7762 50 mg Fasted
n=10 Participants
Participants were randomized to receive a single dose of MK-7762 50 mg.
|
Part 1: Cohort 2: SAD MK-7762 150 mg Fasted
n=10 Participants
Participants were randomized to receive a single dose of MK-7762 150 mg.
|
Part 1: Cohort 3: SAD MK-7762 300 mg Fasted
n=9 Participants
Participants were randomized to receive a single dose of MK-7762 300 mg.
|
Part 1: Cohort 5: SAD MK-7762 1200 mg Fasted
Participants were randomized to receive a single dose of MK-7762 1200 mg.
|
Part 1: Placebo (Pooled)
Participants were randomized to receive a single dose of placebo in capsule sizes matching MK-7762 10 mg, 100 mg, and/or 300 mg.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fasted
Participants were administered a single dose of MK-7762 300 mg in fasted condition.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fed
Participants were administered a single dose of MK-7762 300 mg in fed condition.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: FE Cohort 7: Number of Participants With Clinically Significant Changes in Chemistry Parameters
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 36Population: Safety Population. Data were collected across MAD cohorts based on dose levels, regardless of fasting status.
Participants were randomized to receive MK-7762 100 mg in a fed or fasted state.
Outcome measures
| Measure |
Part 2: Placebo (Pooled)
n=12 Participants
Participants were randomized to receive placebo in fasted state or in fed state with standard breakfast meal in capsule sizes matching MK-7762 100 mg and/or 300 mg.
|
Part 1: Cohort 1: SAD MK-7762 50 mg Fasted
n=16 Participants
Participants were randomized to receive a single dose of MK-7762 50 mg.
|
Part 1: Cohort 2: SAD MK-7762 150 mg Fasted
n=16 Participants
Participants were randomized to receive a single dose of MK-7762 150 mg.
|
Part 1: Cohort 3: SAD MK-7762 300 mg Fasted
n=16 Participants
Participants were randomized to receive a single dose of MK-7762 300 mg.
|
Part 1: Cohort 5: SAD MK-7762 1200 mg Fasted
Participants were randomized to receive a single dose of MK-7762 1200 mg.
|
Part 1: Placebo (Pooled)
Participants were randomized to receive a single dose of placebo in capsule sizes matching MK-7762 10 mg, 100 mg, and/or 300 mg.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fasted
Participants were administered a single dose of MK-7762 300 mg in fasted condition.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fed
Participants were administered a single dose of MK-7762 300 mg in fed condition.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: MAD Cohorts: Number of Participants With Clinically Significant Changes in Chemistry Parameters
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 8Population: Safety Population.
Blood samples were collected for the analysis of Serum coagulation parameters: PT, PTT, and INR.
Outcome measures
| Measure |
Part 2: Placebo (Pooled)
Participants were randomized to receive placebo in fasted state or in fed state with standard breakfast meal in capsule sizes matching MK-7762 100 mg and/or 300 mg.
|
Part 1: Cohort 1: SAD MK-7762 50 mg Fasted
n=10 Participants
Participants were randomized to receive a single dose of MK-7762 50 mg.
|
Part 1: Cohort 2: SAD MK-7762 150 mg Fasted
n=10 Participants
Participants were randomized to receive a single dose of MK-7762 150 mg.
|
Part 1: Cohort 3: SAD MK-7762 300 mg Fasted
n=9 Participants
Participants were randomized to receive a single dose of MK-7762 300 mg.
|
Part 1: Cohort 5: SAD MK-7762 1200 mg Fasted
Participants were randomized to receive a single dose of MK-7762 1200 mg.
|
Part 1: Placebo (Pooled)
Participants were randomized to receive a single dose of placebo in capsule sizes matching MK-7762 10 mg, 100 mg, and/or 300 mg.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fasted
Participants were administered a single dose of MK-7762 300 mg in fasted condition.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fed
Participants were administered a single dose of MK-7762 300 mg in fed condition.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: FE Cohort 7: Number of Participants With Clinically Significant Changes in Serum Coagulation Parameters
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 8Population: Safety Population.
Urine samples were collected for the analysis of urinalysis parameters: Dipstick for pH, specific gravity, glucose, protein, blood, leukocyte esterase, nitrites, ketones, bilirubin, and urobilinogen. Microscopic examination for red blood cells, white blood cells, casts, and bacteria was performed if urine dipstick is positive for protein, blood, leukocyte esterase, or nitrites.
Outcome measures
| Measure |
Part 2: Placebo (Pooled)
Participants were randomized to receive placebo in fasted state or in fed state with standard breakfast meal in capsule sizes matching MK-7762 100 mg and/or 300 mg.
|
Part 1: Cohort 1: SAD MK-7762 50 mg Fasted
n=10 Participants
Participants were randomized to receive a single dose of MK-7762 50 mg.
|
Part 1: Cohort 2: SAD MK-7762 150 mg Fasted
n=10 Participants
Participants were randomized to receive a single dose of MK-7762 150 mg.
|
Part 1: Cohort 3: SAD MK-7762 300 mg Fasted
n=9 Participants
Participants were randomized to receive a single dose of MK-7762 300 mg.
|
Part 1: Cohort 5: SAD MK-7762 1200 mg Fasted
Participants were randomized to receive a single dose of MK-7762 1200 mg.
|
Part 1: Placebo (Pooled)
Participants were randomized to receive a single dose of placebo in capsule sizes matching MK-7762 10 mg, 100 mg, and/or 300 mg.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fasted
Participants were administered a single dose of MK-7762 300 mg in fasted condition.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fed
Participants were administered a single dose of MK-7762 300 mg in fed condition.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: FE Cohort 7: Number of Participants With Clinically Significant Changes in Urinalysis
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 36Population: Safety Population. Data were collected across MAD cohorts based on dose levels, regardless of fasting status.
Blood samples were collected for the analysis of Serum coagulation parameters: PT, PTT, and INR.
Outcome measures
| Measure |
Part 2: Placebo (Pooled)
n=12 Participants
Participants were randomized to receive placebo in fasted state or in fed state with standard breakfast meal in capsule sizes matching MK-7762 100 mg and/or 300 mg.
|
Part 1: Cohort 1: SAD MK-7762 50 mg Fasted
n=16 Participants
Participants were randomized to receive a single dose of MK-7762 50 mg.
|
Part 1: Cohort 2: SAD MK-7762 150 mg Fasted
n=16 Participants
Participants were randomized to receive a single dose of MK-7762 150 mg.
|
Part 1: Cohort 3: SAD MK-7762 300 mg Fasted
n=16 Participants
Participants were randomized to receive a single dose of MK-7762 300 mg.
|
Part 1: Cohort 5: SAD MK-7762 1200 mg Fasted
Participants were randomized to receive a single dose of MK-7762 1200 mg.
|
Part 1: Placebo (Pooled)
Participants were randomized to receive a single dose of placebo in capsule sizes matching MK-7762 10 mg, 100 mg, and/or 300 mg.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fasted
Participants were administered a single dose of MK-7762 300 mg in fasted condition.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fed
Participants were administered a single dose of MK-7762 300 mg in fed condition.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: MAD Cohorts: Number of Participants With Clinically Significant Changes in Serum Coagulation Parameters
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 36Population: Safety Population. Data were collected across MAD cohorts based on dose levels, regardless of fasting status.
Urine samples were collected for the analysis of urinalysis parameters: Dipstick for pH, specific gravity, glucose, protein, blood, leukocyte esterase, nitrites, ketones, bilirubin, and urobilinogen. Microscopic examination for red blood cells, white blood cells, casts, and bacteria was performed if urine dipstick is positive for protein, blood, leukocyte esterase, or nitrites
Outcome measures
| Measure |
Part 2: Placebo (Pooled)
n=12 Participants
Participants were randomized to receive placebo in fasted state or in fed state with standard breakfast meal in capsule sizes matching MK-7762 100 mg and/or 300 mg.
|
Part 1: Cohort 1: SAD MK-7762 50 mg Fasted
n=16 Participants
Participants were randomized to receive a single dose of MK-7762 50 mg.
|
Part 1: Cohort 2: SAD MK-7762 150 mg Fasted
n=16 Participants
Participants were randomized to receive a single dose of MK-7762 150 mg.
|
Part 1: Cohort 3: SAD MK-7762 300 mg Fasted
n=16 Participants
Participants were randomized to receive a single dose of MK-7762 300 mg.
|
Part 1: Cohort 5: SAD MK-7762 1200 mg Fasted
Participants were randomized to receive a single dose of MK-7762 1200 mg.
|
Part 1: Placebo (Pooled)
Participants were randomized to receive a single dose of placebo in capsule sizes matching MK-7762 10 mg, 100 mg, and/or 300 mg.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fasted
Participants were administered a single dose of MK-7762 300 mg in fasted condition.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fed
Participants were administered a single dose of MK-7762 300 mg in fed condition.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: MAD Cohorts: Number of Participants With Clinically Significant Changes in Urinalysis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 8Population: Safety Population.
Vital parameters including temperature, HR, and BP were measured in supine position. Data for number of participants with abnormal clinically significant changes for vital signs have been presented.
Outcome measures
| Measure |
Part 2: Placebo (Pooled)
Participants were randomized to receive placebo in fasted state or in fed state with standard breakfast meal in capsule sizes matching MK-7762 100 mg and/or 300 mg.
|
Part 1: Cohort 1: SAD MK-7762 50 mg Fasted
n=10 Participants
Participants were randomized to receive a single dose of MK-7762 50 mg.
|
Part 1: Cohort 2: SAD MK-7762 150 mg Fasted
n=10 Participants
Participants were randomized to receive a single dose of MK-7762 150 mg.
|
Part 1: Cohort 3: SAD MK-7762 300 mg Fasted
n=9 Participants
Participants were randomized to receive a single dose of MK-7762 300 mg.
|
Part 1: Cohort 5: SAD MK-7762 1200 mg Fasted
Participants were randomized to receive a single dose of MK-7762 1200 mg.
|
Part 1: Placebo (Pooled)
Participants were randomized to receive a single dose of placebo in capsule sizes matching MK-7762 10 mg, 100 mg, and/or 300 mg.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fasted
Participants were administered a single dose of MK-7762 300 mg in fasted condition.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fed
Participants were administered a single dose of MK-7762 300 mg in fed condition.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: FE Cohort 7: Number of Participants With Clinically Significant Changes in Vital Parameters
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 36Population: Safety Population. Data were collected across MAD cohorts based on dose levels, regardless of fasting status.
Vital parameters including temperature, HR, and BP were measured in supine position. Data for number of participants with abnormal clinically significant changes for vital signs have been presented.
Outcome measures
| Measure |
Part 2: Placebo (Pooled)
n=12 Participants
Participants were randomized to receive placebo in fasted state or in fed state with standard breakfast meal in capsule sizes matching MK-7762 100 mg and/or 300 mg.
|
Part 1: Cohort 1: SAD MK-7762 50 mg Fasted
n=16 Participants
Participants were randomized to receive a single dose of MK-7762 50 mg.
|
Part 1: Cohort 2: SAD MK-7762 150 mg Fasted
n=16 Participants
Participants were randomized to receive a single dose of MK-7762 150 mg.
|
Part 1: Cohort 3: SAD MK-7762 300 mg Fasted
n=16 Participants
Participants were randomized to receive a single dose of MK-7762 300 mg.
|
Part 1: Cohort 5: SAD MK-7762 1200 mg Fasted
Participants were randomized to receive a single dose of MK-7762 1200 mg.
|
Part 1: Placebo (Pooled)
Participants were randomized to receive a single dose of placebo in capsule sizes matching MK-7762 10 mg, 100 mg, and/or 300 mg.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fasted
Participants were administered a single dose of MK-7762 300 mg in fasted condition.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fed
Participants were administered a single dose of MK-7762 300 mg in fed condition.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: MAD Cohorts: Number of Participants With Clinically Significant Changes in Vital Parameters
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 8Population: Safety Population.
ECG parameters included HR, RR interval, PR interval, QRS duration, QT interval, and QTcF.
Outcome measures
| Measure |
Part 2: Placebo (Pooled)
Participants were randomized to receive placebo in fasted state or in fed state with standard breakfast meal in capsule sizes matching MK-7762 100 mg and/or 300 mg.
|
Part 1: Cohort 1: SAD MK-7762 50 mg Fasted
n=10 Participants
Participants were randomized to receive a single dose of MK-7762 50 mg.
|
Part 1: Cohort 2: SAD MK-7762 150 mg Fasted
n=10 Participants
Participants were randomized to receive a single dose of MK-7762 150 mg.
|
Part 1: Cohort 3: SAD MK-7762 300 mg Fasted
n=9 Participants
Participants were randomized to receive a single dose of MK-7762 300 mg.
|
Part 1: Cohort 5: SAD MK-7762 1200 mg Fasted
Participants were randomized to receive a single dose of MK-7762 1200 mg.
|
Part 1: Placebo (Pooled)
Participants were randomized to receive a single dose of placebo in capsule sizes matching MK-7762 10 mg, 100 mg, and/or 300 mg.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fasted
Participants were administered a single dose of MK-7762 300 mg in fasted condition.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fed
Participants were administered a single dose of MK-7762 300 mg in fed condition.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: FE Cohort 7: Number of Participants With Clinically Significant Changes in ECG Parameters
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 36Population: Safety Population. Data were collected across MAD cohorts based on dose levels, regardless of fasting status.
ECG parameters included HR, RR interval, PR interval, QRS duration, QT interval, and QTcF.
Outcome measures
| Measure |
Part 2: Placebo (Pooled)
n=12 Participants
Participants were randomized to receive placebo in fasted state or in fed state with standard breakfast meal in capsule sizes matching MK-7762 100 mg and/or 300 mg.
|
Part 1: Cohort 1: SAD MK-7762 50 mg Fasted
n=16 Participants
Participants were randomized to receive a single dose of MK-7762 50 mg.
|
Part 1: Cohort 2: SAD MK-7762 150 mg Fasted
n=16 Participants
Participants were randomized to receive a single dose of MK-7762 150 mg.
|
Part 1: Cohort 3: SAD MK-7762 300 mg Fasted
n=16 Participants
Participants were randomized to receive a single dose of MK-7762 300 mg.
|
Part 1: Cohort 5: SAD MK-7762 1200 mg Fasted
Participants were randomized to receive a single dose of MK-7762 1200 mg.
|
Part 1: Placebo (Pooled)
Participants were randomized to receive a single dose of placebo in capsule sizes matching MK-7762 10 mg, 100 mg, and/or 300 mg.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fasted
Participants were administered a single dose of MK-7762 300 mg in fasted condition.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fed
Participants were administered a single dose of MK-7762 300 mg in fed condition.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: MAD Cohorts: Number of Participants With Clinically Significant Changes in ECG Parameters
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose and at 1, 2, 3, 4, 5, 6, 8, and 12 hours post-dose and 24 and 36 hours post-dose (Day 2); Day 3: 48 hours post-dose; Day 4: 72 hours post-dose; Day 7: Within ±1-hour time window of time of study drug administration on Day 1Population: Pharmacokinetic Population comprised of all participants who received MK-7762 and have at least one non-zero pharmacokinetic result available.
Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. In FE cohort 6 for fasted and fed conditions, data has been collected for all fasted and fed participants. The data hence has been presented for all fasted and fed participants.
Outcome measures
| Measure |
Part 2: Placebo (Pooled)
n=6 Participants
Participants were randomized to receive placebo in fasted state or in fed state with standard breakfast meal in capsule sizes matching MK-7762 100 mg and/or 300 mg.
|
Part 1: Cohort 1: SAD MK-7762 50 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 50 mg.
|
Part 1: Cohort 2: SAD MK-7762 150 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 150 mg.
|
Part 1: Cohort 3: SAD MK-7762 300 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 300 mg.
|
Part 1: Cohort 5: SAD MK-7762 1200 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 1200 mg.
|
Part 1: Placebo (Pooled)
n=8 Participants
Participants were randomized to receive a single dose of placebo in capsule sizes matching MK-7762 10 mg, 100 mg, and/or 300 mg.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fasted
n=8 Participants
Participants were administered a single dose of MK-7762 300 mg in fasted condition.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fed
Participants were administered a single dose of MK-7762 300 mg in fed condition.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Maximum Plasma Drug Concentration (Cmax) of MK-7762
|
7.240 Micromoles
Geometric Coefficient of Variation 27.2
|
1.440 Micromoles
Geometric Coefficient of Variation 15.5
|
3.590 Micromoles
Geometric Coefficient of Variation 22.1
|
7.310 Micromoles
Geometric Coefficient of Variation 30.0
|
7.770 Micromoles
Geometric Coefficient of Variation 19.1
|
6.190 Micromoles
Geometric Coefficient of Variation 20.0
|
9.680 Micromoles
Geometric Coefficient of Variation 17.0
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose and at 1, 2, 3, 4, 5, 6, 8, and 12 hours post-dose and 24 and 36 hours post-dose (Day 2); Day 3: 48 hours post-dose; Day 4: 72 hours post-dose; Day 7: Within ±1-hour time window of time of study drug administration on Day 1Population: Pharmacokinetic Population.
Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. In FE cohort 6 for fasted and fed conditions, data has been collected for all fasted and fed participants. The data hence has been presented for all fasted and fed participants.
Outcome measures
| Measure |
Part 2: Placebo (Pooled)
n=6 Participants
Participants were randomized to receive placebo in fasted state or in fed state with standard breakfast meal in capsule sizes matching MK-7762 100 mg and/or 300 mg.
|
Part 1: Cohort 1: SAD MK-7762 50 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 50 mg.
|
Part 1: Cohort 2: SAD MK-7762 150 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 150 mg.
|
Part 1: Cohort 3: SAD MK-7762 300 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 300 mg.
|
Part 1: Cohort 5: SAD MK-7762 1200 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 1200 mg.
|
Part 1: Placebo (Pooled)
n=8 Participants
Participants were randomized to receive a single dose of placebo in capsule sizes matching MK-7762 10 mg, 100 mg, and/or 300 mg.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fasted
n=8 Participants
Participants were administered a single dose of MK-7762 300 mg in fasted condition.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fed
Participants were administered a single dose of MK-7762 300 mg in fed condition.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Time to Maximum Plasma Drug Concentration (Tmax) of MK-7762
|
24.00 Hours
Interval 8.0 to 36.0
|
4.50 Hours
Interval 3.0 to 8.0
|
10.00 Hours
Interval 5.0 to 24.0
|
10.02 Hours
Interval 6.0 to 24.0
|
30.01 Hours
Interval 8.01 to 72.1
|
18.00 Hours
Interval 6.0 to 24.0
|
7.00 Hours
Interval 5.0 to 24.0
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose and at 1, 2, 3, 4, 5, 6, 8, and 12 hours post-dose and 24 and 36 hours post-dose (Day 2); Day 3: 48 hours post-dose; Day 4: 72 hours post-dose; Day 7: Within ±1-hour time window of time of study drug administration on Day 1Population: Pharmacokinetic Population.
Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. In FE cohort 6 for fasted and fed conditions, data has been collected for all fasted and fed participants. The data hence has been presented for all fasted and fed participants.
Outcome measures
| Measure |
Part 2: Placebo (Pooled)
n=6 Participants
Participants were randomized to receive placebo in fasted state or in fed state with standard breakfast meal in capsule sizes matching MK-7762 100 mg and/or 300 mg.
|
Part 1: Cohort 1: SAD MK-7762 50 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 50 mg.
|
Part 1: Cohort 2: SAD MK-7762 150 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 150 mg.
|
Part 1: Cohort 3: SAD MK-7762 300 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 300 mg.
|
Part 1: Cohort 5: SAD MK-7762 1200 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 1200 mg.
|
Part 1: Placebo (Pooled)
n=8 Participants
Participants were randomized to receive a single dose of placebo in capsule sizes matching MK-7762 10 mg, 100 mg, and/or 300 mg.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fasted
n=8 Participants
Participants were administered a single dose of MK-7762 300 mg in fasted condition.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fed
Participants were administered a single dose of MK-7762 300 mg in fed condition.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Area Under the Concentration-time Curve (AUC) Calculated to Last Quantifiable Observed Sample (AUClast) of MK-7762
|
473.0 hours*micromoles
Geometric Coefficient of Variation 30.5
|
43.90 hours*micromoles
Geometric Coefficient of Variation 30.8
|
184.0 hours*micromoles
Geometric Coefficient of Variation 21.2
|
309.0 hours*micromoles
Geometric Coefficient of Variation 34.0
|
676.0 hours*micromoles
Geometric Coefficient of Variation 41.0
|
341.0 hours*micromoles
Geometric Coefficient of Variation 33.5
|
394.0 hours*micromoles
Geometric Coefficient of Variation 26.8
|
—
|
SECONDARY outcome
Timeframe: Up to 24 hrs post dosePopulation: Pharmacokinetic Population.
Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. In FE cohort 6 for fasted and fed conditions, data has been collected for all fasted and fed participants. The data hence has been presented for all fasted and fed participants.
Outcome measures
| Measure |
Part 2: Placebo (Pooled)
n=6 Participants
Participants were randomized to receive placebo in fasted state or in fed state with standard breakfast meal in capsule sizes matching MK-7762 100 mg and/or 300 mg.
|
Part 1: Cohort 1: SAD MK-7762 50 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 50 mg.
|
Part 1: Cohort 2: SAD MK-7762 150 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 150 mg.
|
Part 1: Cohort 3: SAD MK-7762 300 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 300 mg.
|
Part 1: Cohort 5: SAD MK-7762 1200 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 1200 mg.
|
Part 1: Placebo (Pooled)
n=8 Participants
Participants were randomized to receive a single dose of placebo in capsule sizes matching MK-7762 10 mg, 100 mg, and/or 300 mg.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fasted
n=8 Participants
Participants were administered a single dose of MK-7762 300 mg in fasted condition.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fed
Participants were administered a single dose of MK-7762 300 mg in fed condition.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: AUC Over First 24h (AUC0-24) of MK-7762
|
143.0 hours*micromoles
Geometric Coefficient of Variation 29.6
|
25.80 hours*micromoles
Geometric Coefficient of Variation 19.6
|
71.40 hours*micromoles
Geometric Coefficient of Variation 21.5
|
136.0 hours*micromoles
Geometric Coefficient of Variation 25.4
|
128.0 hours*micromoles
Geometric Coefficient of Variation 18.1
|
119.0 hours*micromoles
Geometric Coefficient of Variation 19.9
|
164.0 hours*micromoles
Geometric Coefficient of Variation 17.3
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose and at 1, 2, 3, 4, 5, 6, 8, and 12 hours post-dose and 24 and 36 hours post-dose (Day 2); Day 3: 48 hours post-dose; Day 4: 72 hours post-dose; Day 7: Within ±1-hour time window of time of study drug administration on Day 1Population: Pharmacokinetic Population.
Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. In FE cohort 6 for fasted and fed conditions, data has been collected for all fasted and fed participants. The data hence has been presented for all fasted and fed participants.
Outcome measures
| Measure |
Part 2: Placebo (Pooled)
n=6 Participants
Participants were randomized to receive placebo in fasted state or in fed state with standard breakfast meal in capsule sizes matching MK-7762 100 mg and/or 300 mg.
|
Part 1: Cohort 1: SAD MK-7762 50 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 50 mg.
|
Part 1: Cohort 2: SAD MK-7762 150 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 150 mg.
|
Part 1: Cohort 3: SAD MK-7762 300 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 300 mg.
|
Part 1: Cohort 5: SAD MK-7762 1200 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 1200 mg.
|
Part 1: Placebo (Pooled)
n=8 Participants
Participants were randomized to receive a single dose of placebo in capsule sizes matching MK-7762 10 mg, 100 mg, and/or 300 mg.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fasted
n=8 Participants
Participants were administered a single dose of MK-7762 300 mg in fasted condition.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fed
Participants were administered a single dose of MK-7762 300 mg in fed condition.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: AUC Extrapolated to Infinity (AUC0-inf) of MK-7762
|
490.0 hours*micromoles
Geometric Coefficient of Variation 30.0
|
50.50 hours*micromoles
Geometric Coefficient of Variation 29.8
|
215.0 hours*micromoles
Geometric Coefficient of Variation 11.8
|
326.0 hours*micromoles
Geometric Coefficient of Variation 32.3
|
486.0 hours*micromoles
Geometric Coefficient of Variation 11.3
|
362.0 hours*micromoles
Geometric Coefficient of Variation 30.2
|
406.0 hours*micromoles
Geometric Coefficient of Variation 27.0
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose and at 1, 2, 3, 4, 5, 6, 8, and 12 hours post-dose and 24 and 36 hours post-dose (Day 2); Day 3: 48 hours post-dose; Day 4: 72 hours post-dose; Day 7: Within ±1-hour time window of time of study drug administration on Day 1Population: Pharmacokinetic Population.
Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. In FE cohort 6 for fasted and fed conditions, data has been collected for all fasted and fed participants. The data hence has been presented for all fasted and fed participants.
Outcome measures
| Measure |
Part 2: Placebo (Pooled)
n=6 Participants
Participants were randomized to receive placebo in fasted state or in fed state with standard breakfast meal in capsule sizes matching MK-7762 100 mg and/or 300 mg.
|
Part 1: Cohort 1: SAD MK-7762 50 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 50 mg.
|
Part 1: Cohort 2: SAD MK-7762 150 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 150 mg.
|
Part 1: Cohort 3: SAD MK-7762 300 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 300 mg.
|
Part 1: Cohort 5: SAD MK-7762 1200 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 1200 mg.
|
Part 1: Placebo (Pooled)
n=8 Participants
Participants were randomized to receive a single dose of placebo in capsule sizes matching MK-7762 10 mg, 100 mg, and/or 300 mg.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fasted
n=8 Participants
Participants were administered a single dose of MK-7762 300 mg in fasted condition.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fed
Participants were administered a single dose of MK-7762 300 mg in fed condition.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Terminal Elimination Half-life (t½) of MK-7762
|
21.7 Hours
Geometric Coefficient of Variation 13.9
|
20.3 Hours
Geometric Coefficient of Variation 15.6
|
27.4 Hours
Geometric Coefficient of Variation 9.4
|
21.2 Hours
Geometric Coefficient of Variation 19.7
|
22.2 Hours
Geometric Coefficient of Variation 14.3
|
25.3 Hours
Geometric Coefficient of Variation 20.0
|
24.8 Hours
Geometric Coefficient of Variation 22.9
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose and at 1, 2, 3, 4, 5, 6, 8, and 12 hours post-dose and 24 and 36 hours post-dose (Day 2); Day 3: 48 hours post-dose; Day 4: 72 hours post-dose; Day 7: Within ±1-hour time window of time of study drug administration on Day 1Population: Pharmacokinetic Population. Only those participants with data available at specified time points have been presented.
Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. In FE cohort 6 for fasted and fed conditions, data has been collected for all fasted and fed participants. The data hence has been presented for all fasted and fed participants.
Outcome measures
| Measure |
Part 2: Placebo (Pooled)
n=6 Participants
Participants were randomized to receive placebo in fasted state or in fed state with standard breakfast meal in capsule sizes matching MK-7762 100 mg and/or 300 mg.
|
Part 1: Cohort 1: SAD MK-7762 50 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 50 mg.
|
Part 1: Cohort 2: SAD MK-7762 150 mg Fasted
n=5 Participants
Participants were randomized to receive a single dose of MK-7762 150 mg.
|
Part 1: Cohort 3: SAD MK-7762 300 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 300 mg.
|
Part 1: Cohort 5: SAD MK-7762 1200 mg Fasted
n=3 Participants
Participants were randomized to receive a single dose of MK-7762 1200 mg.
|
Part 1: Placebo (Pooled)
n=8 Participants
Participants were randomized to receive a single dose of placebo in capsule sizes matching MK-7762 10 mg, 100 mg, and/or 300 mg.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fasted
n=8 Participants
Participants were administered a single dose of MK-7762 300 mg in fasted condition.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fed
Participants were administered a single dose of MK-7762 300 mg in fed condition.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Oral Clearance (CL/F) of MK-7762
|
2.92 Liters per hour
Geometric Coefficient of Variation 30.0
|
2.36 Liters per hour
Geometric Coefficient of Variation 29.8
|
1.67 Liters per hour
Geometric Coefficient of Variation 11.8
|
2.19 Liters per hour
Geometric Coefficient of Variation 32.3
|
5.89 Liters per hour
Geometric Coefficient of Variation 11.3
|
1.98 Liters per hour
Geometric Coefficient of Variation 30.2
|
1.76 Liters per hour
Geometric Coefficient of Variation 27.0
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose and at 1, 2, 3, 4, 5, 6, 8, and 12 hours post-dose and 24 and 36 hours post-dose (Day 2); Day 3: 48 hours post-dose; Day 4: 72 hours post-dose; Day 7: Within ±1-hour time window of time of study drug administration on Day 1Population: Pharmacokinetic Population. Only those participants with data available at specified time points have been presented.
Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. In FE cohort 6 for fasted and fed conditions, data has been collected for all fasted and fed participants. The data hence has been presented for all fasted and fed participants.
Outcome measures
| Measure |
Part 2: Placebo (Pooled)
n=6 Participants
Participants were randomized to receive placebo in fasted state or in fed state with standard breakfast meal in capsule sizes matching MK-7762 100 mg and/or 300 mg.
|
Part 1: Cohort 1: SAD MK-7762 50 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 50 mg.
|
Part 1: Cohort 2: SAD MK-7762 150 mg Fasted
n=5 Participants
Participants were randomized to receive a single dose of MK-7762 150 mg.
|
Part 1: Cohort 3: SAD MK-7762 300 mg Fasted
n=6 Participants
Participants were randomized to receive a single dose of MK-7762 300 mg.
|
Part 1: Cohort 5: SAD MK-7762 1200 mg Fasted
n=3 Participants
Participants were randomized to receive a single dose of MK-7762 1200 mg.
|
Part 1: Placebo (Pooled)
n=8 Participants
Participants were randomized to receive a single dose of placebo in capsule sizes matching MK-7762 10 mg, 100 mg, and/or 300 mg.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fasted
n=8 Participants
Participants were administered a single dose of MK-7762 300 mg in fasted condition.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fed
Participants were administered a single dose of MK-7762 300 mg in fed condition.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Oral Volume of Distribution (Vd/F) of MK-7762
|
91.2 Liters
Geometric Coefficient of Variation 27.4
|
69.3 Liters
Geometric Coefficient of Variation 15.2
|
65.9 Liters
Geometric Coefficient of Variation 14.2
|
67.1 Liters
Geometric Coefficient of Variation 26.8
|
188 Liters
Geometric Coefficient of Variation 10.1
|
72.0 Liters
Geometric Coefficient of Variation 15.8
|
62.9 Liters
Geometric Coefficient of Variation 15.9
|
—
|
SECONDARY outcome
Timeframe: Day 1: pre-dose and at 1, 2, 4, 6, 8, and 12 hours post dose and 24- and 36-hours post-dose (Day 2); Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6: 120 hours; Day 7: 144 hours; Day 8: 168 hours post dosePopulation: Pharmacokinetic Population.
Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods.
Outcome measures
| Measure |
Part 2: Placebo (Pooled)
Participants were randomized to receive placebo in fasted state or in fed state with standard breakfast meal in capsule sizes matching MK-7762 100 mg and/or 300 mg.
|
Part 1: Cohort 1: SAD MK-7762 50 mg Fasted
n=10 Participants
Participants were randomized to receive a single dose of MK-7762 50 mg.
|
Part 1: Cohort 2: SAD MK-7762 150 mg Fasted
n=10 Participants
Participants were randomized to receive a single dose of MK-7762 150 mg.
|
Part 1: Cohort 3: SAD MK-7762 300 mg Fasted
n=9 Participants
Participants were randomized to receive a single dose of MK-7762 300 mg.
|
Part 1: Cohort 5: SAD MK-7762 1200 mg Fasted
Participants were randomized to receive a single dose of MK-7762 1200 mg.
|
Part 1: Placebo (Pooled)
Participants were randomized to receive a single dose of placebo in capsule sizes matching MK-7762 10 mg, 100 mg, and/or 300 mg.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fasted
Participants were administered a single dose of MK-7762 300 mg in fasted condition.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fed
Participants were administered a single dose of MK-7762 300 mg in fed condition.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: FE Cohort 7: Cmax of MK-7762
|
—
|
2720 Nanograms per milliliter
Geometric Coefficient of Variation 18.3
|
6790 Nanograms per milliliter
Geometric Coefficient of Variation 10.3
|
5080 Nanograms per milliliter
Geometric Coefficient of Variation 25.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: pre-dose and at 1, 2, 4, 6, 8, and 12 hours post dose and 24- and 36-hours post-dose (Day 2); Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6: 120 hours; Day 7: 144 hours; Day 8: 168 hours post dosePopulation: Pharmacokinetic Population.
Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods.
Outcome measures
| Measure |
Part 2: Placebo (Pooled)
Participants were randomized to receive placebo in fasted state or in fed state with standard breakfast meal in capsule sizes matching MK-7762 100 mg and/or 300 mg.
|
Part 1: Cohort 1: SAD MK-7762 50 mg Fasted
n=10 Participants
Participants were randomized to receive a single dose of MK-7762 50 mg.
|
Part 1: Cohort 2: SAD MK-7762 150 mg Fasted
n=10 Participants
Participants were randomized to receive a single dose of MK-7762 150 mg.
|
Part 1: Cohort 3: SAD MK-7762 300 mg Fasted
n=9 Participants
Participants were randomized to receive a single dose of MK-7762 300 mg.
|
Part 1: Cohort 5: SAD MK-7762 1200 mg Fasted
Participants were randomized to receive a single dose of MK-7762 1200 mg.
|
Part 1: Placebo (Pooled)
Participants were randomized to receive a single dose of placebo in capsule sizes matching MK-7762 10 mg, 100 mg, and/or 300 mg.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fasted
Participants were administered a single dose of MK-7762 300 mg in fasted condition.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fed
Participants were administered a single dose of MK-7762 300 mg in fed condition.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: FE Cohort 7: Tmax of MK-7762
|
—
|
24.0 Hours
Interval 6.0 to 48.0
|
8.00 Hours
Interval 6.0 to 24.02
|
6.08 Hours
Interval 6.0 to 12.1
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: pre-dose and at 1, 2, 4, 6, 8, and 12 hours post dose and 24- and 36-hours post-dose (Day 2); Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6: 120 hours; Day 7: 144 hours; Day 8: 168 hours post dosePopulation: Pharmacokinetic Population.
Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods.
Outcome measures
| Measure |
Part 2: Placebo (Pooled)
Participants were randomized to receive placebo in fasted state or in fed state with standard breakfast meal in capsule sizes matching MK-7762 100 mg and/or 300 mg.
|
Part 1: Cohort 1: SAD MK-7762 50 mg Fasted
n=10 Participants
Participants were randomized to receive a single dose of MK-7762 50 mg.
|
Part 1: Cohort 2: SAD MK-7762 150 mg Fasted
n=10 Participants
Participants were randomized to receive a single dose of MK-7762 150 mg.
|
Part 1: Cohort 3: SAD MK-7762 300 mg Fasted
n=9 Participants
Participants were randomized to receive a single dose of MK-7762 300 mg.
|
Part 1: Cohort 5: SAD MK-7762 1200 mg Fasted
Participants were randomized to receive a single dose of MK-7762 1200 mg.
|
Part 1: Placebo (Pooled)
Participants were randomized to receive a single dose of placebo in capsule sizes matching MK-7762 10 mg, 100 mg, and/or 300 mg.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fasted
Participants were administered a single dose of MK-7762 300 mg in fasted condition.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fed
Participants were administered a single dose of MK-7762 300 mg in fed condition.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: FE Cohort 7: AUClast of MK-7762
|
—
|
179000 Hours*nanograms per milliliter
Geometric Coefficient of Variation 25.3
|
341000 Hours*nanograms per milliliter
Geometric Coefficient of Variation 19.9
|
270000 Hours*nanograms per milliliter
Geometric Coefficient of Variation 24.5
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: pre-dose and at 1, 2, 4, 6, 8, and 12 hours post dose and 24- and 36-hours post-dose (Day 2); Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6: 120 hours; Day 7: 144 hours; Day 8: 168 hours post dosePopulation: Pharmacokinetic Population.
Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods.
Outcome measures
| Measure |
Part 2: Placebo (Pooled)
Participants were randomized to receive placebo in fasted state or in fed state with standard breakfast meal in capsule sizes matching MK-7762 100 mg and/or 300 mg.
|
Part 1: Cohort 1: SAD MK-7762 50 mg Fasted
n=10 Participants
Participants were randomized to receive a single dose of MK-7762 50 mg.
|
Part 1: Cohort 2: SAD MK-7762 150 mg Fasted
n=10 Participants
Participants were randomized to receive a single dose of MK-7762 150 mg.
|
Part 1: Cohort 3: SAD MK-7762 300 mg Fasted
n=9 Participants
Participants were randomized to receive a single dose of MK-7762 300 mg.
|
Part 1: Cohort 5: SAD MK-7762 1200 mg Fasted
Participants were randomized to receive a single dose of MK-7762 1200 mg.
|
Part 1: Placebo (Pooled)
Participants were randomized to receive a single dose of placebo in capsule sizes matching MK-7762 10 mg, 100 mg, and/or 300 mg.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fasted
Participants were administered a single dose of MK-7762 300 mg in fasted condition.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fed
Participants were administered a single dose of MK-7762 300 mg in fed condition.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: FE Cohort 7: AUC0-inf of MK-7762
|
—
|
NA Hours*nanograms per milliliter
Geometric Coefficient of Variation NA
The terminal elimination phase could not be identified from the concentration-time profile over the study period; hence, AUC(0-infinity) could not be estimated.
|
NA Hours*nanograms per milliliter
Geometric Coefficient of Variation NA
The terminal elimination phase could not be identified from the concentration-time profile over the study period; hence, AUC(0-infinity) could not be estimated.
|
NA Hours*nanograms per milliliter
Geometric Coefficient of Variation NA
The terminal elimination phase could not be identified from the concentration-time profile over the study period; hence, AUC(0-infinity) could not be estimated.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 24 hours post dosePopulation: Pharmacokinetic Population.
Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods.
Outcome measures
| Measure |
Part 2: Placebo (Pooled)
Participants were randomized to receive placebo in fasted state or in fed state with standard breakfast meal in capsule sizes matching MK-7762 100 mg and/or 300 mg.
|
Part 1: Cohort 1: SAD MK-7762 50 mg Fasted
n=10 Participants
Participants were randomized to receive a single dose of MK-7762 50 mg.
|
Part 1: Cohort 2: SAD MK-7762 150 mg Fasted
n=10 Participants
Participants were randomized to receive a single dose of MK-7762 150 mg.
|
Part 1: Cohort 3: SAD MK-7762 300 mg Fasted
n=9 Participants
Participants were randomized to receive a single dose of MK-7762 300 mg.
|
Part 1: Cohort 5: SAD MK-7762 1200 mg Fasted
Participants were randomized to receive a single dose of MK-7762 1200 mg.
|
Part 1: Placebo (Pooled)
Participants were randomized to receive a single dose of placebo in capsule sizes matching MK-7762 10 mg, 100 mg, and/or 300 mg.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fasted
Participants were administered a single dose of MK-7762 300 mg in fasted condition.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fed
Participants were administered a single dose of MK-7762 300 mg in fed condition.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: FE Cohort 7: AUC0-24 of MK-7762
|
—
|
52800 Hours*nanograms per milliliter
Geometric Coefficient of Variation 20.8
|
125000 Hours*nanograms per milliliter
Geometric Coefficient of Variation 9.2
|
94900 Hours*nanograms per milliliter
Geometric Coefficient of Variation 22.3
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: pre-dose and at 1, 2, 4, 6, 8, and 12 hours post dose and 24- and 36-hours post-dose (Day 2); Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6: 120 hours; Day 7: 144 hours; Day 8: 168 hours post dosePopulation: Pharmacokinetic Population.
Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods.
Outcome measures
| Measure |
Part 2: Placebo (Pooled)
Participants were randomized to receive placebo in fasted state or in fed state with standard breakfast meal in capsule sizes matching MK-7762 100 mg and/or 300 mg.
|
Part 1: Cohort 1: SAD MK-7762 50 mg Fasted
n=10 Participants
Participants were randomized to receive a single dose of MK-7762 50 mg.
|
Part 1: Cohort 2: SAD MK-7762 150 mg Fasted
n=10 Participants
Participants were randomized to receive a single dose of MK-7762 150 mg.
|
Part 1: Cohort 3: SAD MK-7762 300 mg Fasted
n=9 Participants
Participants were randomized to receive a single dose of MK-7762 300 mg.
|
Part 1: Cohort 5: SAD MK-7762 1200 mg Fasted
Participants were randomized to receive a single dose of MK-7762 1200 mg.
|
Part 1: Placebo (Pooled)
Participants were randomized to receive a single dose of placebo in capsule sizes matching MK-7762 10 mg, 100 mg, and/or 300 mg.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fasted
Participants were administered a single dose of MK-7762 300 mg in fasted condition.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fed
Participants were administered a single dose of MK-7762 300 mg in fed condition.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: FE Cohort 7: t½ of MK-7762
|
—
|
NA Hours
Geometric Coefficient of Variation NA
The terminal elimination phase could not be identified from the concentration-time profile over the study period; hence, t1/2 could not be estimated.
|
NA Hours
Geometric Coefficient of Variation NA
The terminal elimination phase could not be identified from the concentration-time profile over the study period; hence, t1/2 could not be estimated.
|
NA Hours
Geometric Coefficient of Variation NA
The terminal elimination phase could not be identified from the concentration-time profile over the study period; hence, t1/2 could not be estimated.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: pre-dose and at 1, 2, 4, 6, 8, and 12 hours post dose and 24- and 36-hours post-dose (Day 2); Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6: 120 hours; Day 7: 144 hours; Day 8: 168 hours post dosePopulation: Pharmacokinetic Population.
Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods.
Outcome measures
| Measure |
Part 2: Placebo (Pooled)
Participants were randomized to receive placebo in fasted state or in fed state with standard breakfast meal in capsule sizes matching MK-7762 100 mg and/or 300 mg.
|
Part 1: Cohort 1: SAD MK-7762 50 mg Fasted
n=10 Participants
Participants were randomized to receive a single dose of MK-7762 50 mg.
|
Part 1: Cohort 2: SAD MK-7762 150 mg Fasted
n=10 Participants
Participants were randomized to receive a single dose of MK-7762 150 mg.
|
Part 1: Cohort 3: SAD MK-7762 300 mg Fasted
n=9 Participants
Participants were randomized to receive a single dose of MK-7762 300 mg.
|
Part 1: Cohort 5: SAD MK-7762 1200 mg Fasted
Participants were randomized to receive a single dose of MK-7762 1200 mg.
|
Part 1: Placebo (Pooled)
Participants were randomized to receive a single dose of placebo in capsule sizes matching MK-7762 10 mg, 100 mg, and/or 300 mg.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fasted
Participants were administered a single dose of MK-7762 300 mg in fasted condition.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fed
Participants were administered a single dose of MK-7762 300 mg in fed condition.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: FE Cohort 7: CL/F of MK-7762
|
—
|
NA Liters per hour
Geometric Coefficient of Variation NA
The terminal elimination phase could not be identified from the concentration-time profile over the study period; hence, CL/F could not be estimated.
|
NA Liters per hour
Geometric Coefficient of Variation NA
The terminal elimination phase could not be identified from the concentration-time profile over the study period; hence, CL/F could not be estimated.
|
NA Liters per hour
Geometric Coefficient of Variation NA
The terminal elimination phase could not be identified from the concentration-time profile over the study period; hence, CL/F could not be estimated.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: pre-dose and at 1, 2, 4, 6, 8, and 12 hours post dose and 24- and 36-hours post-dose (Day 2); Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6: 120 hours; Day 7: 144 hours; Day 8: 168 hours post dosePopulation: Pharmacokinetic Population.
Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods.
Outcome measures
| Measure |
Part 2: Placebo (Pooled)
Participants were randomized to receive placebo in fasted state or in fed state with standard breakfast meal in capsule sizes matching MK-7762 100 mg and/or 300 mg.
|
Part 1: Cohort 1: SAD MK-7762 50 mg Fasted
n=10 Participants
Participants were randomized to receive a single dose of MK-7762 50 mg.
|
Part 1: Cohort 2: SAD MK-7762 150 mg Fasted
n=10 Participants
Participants were randomized to receive a single dose of MK-7762 150 mg.
|
Part 1: Cohort 3: SAD MK-7762 300 mg Fasted
n=9 Participants
Participants were randomized to receive a single dose of MK-7762 300 mg.
|
Part 1: Cohort 5: SAD MK-7762 1200 mg Fasted
Participants were randomized to receive a single dose of MK-7762 1200 mg.
|
Part 1: Placebo (Pooled)
Participants were randomized to receive a single dose of placebo in capsule sizes matching MK-7762 10 mg, 100 mg, and/or 300 mg.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fasted
Participants were administered a single dose of MK-7762 300 mg in fasted condition.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fed
Participants were administered a single dose of MK-7762 300 mg in fed condition.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: FE Cohort 7: Vd/F of MK-7762
|
—
|
NA Liters
Geometric Coefficient of Variation NA
The terminal elimination phase could not be identified from the concentration-time profile over the study period; hence, Vd/F could not be estimated.
|
NA Liters
Geometric Coefficient of Variation NA
The terminal elimination phase could not be identified from the concentration-time profile over the study period; hence, Vd/F could not be estimated.
|
NA Liters
Geometric Coefficient of Variation NA
The terminal elimination phase could not be identified from the concentration-time profile over the study period; hence, Vd/F could not be estimated.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 28: pre-dose, and at 1, 2, 4, 6, 8, and 12 hours post dosePopulation: Pharmacokinetic Population.
Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods.
Outcome measures
| Measure |
Part 2: Placebo (Pooled)
n=7 Participants
Participants were randomized to receive placebo in fasted state or in fed state with standard breakfast meal in capsule sizes matching MK-7762 100 mg and/or 300 mg.
|
Part 1: Cohort 1: SAD MK-7762 50 mg Fasted
n=7 Participants
Participants were randomized to receive a single dose of MK-7762 50 mg.
|
Part 1: Cohort 2: SAD MK-7762 150 mg Fasted
n=7 Participants
Participants were randomized to receive a single dose of MK-7762 150 mg.
|
Part 1: Cohort 3: SAD MK-7762 300 mg Fasted
n=7 Participants
Participants were randomized to receive a single dose of MK-7762 300 mg.
|
Part 1: Cohort 5: SAD MK-7762 1200 mg Fasted
n=7 Participants
Participants were randomized to receive a single dose of MK-7762 1200 mg.
|
Part 1: Placebo (Pooled)
n=7 Participants
Participants were randomized to receive a single dose of placebo in capsule sizes matching MK-7762 10 mg, 100 mg, and/or 300 mg.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fasted
Participants were administered a single dose of MK-7762 300 mg in fasted condition.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fed
Participants were administered a single dose of MK-7762 300 mg in fed condition.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: MAD Cohorts: CL/F of MK-7762
|
1.77 Liters per hour
Geometric Coefficient of Variation 19.7
|
1.90 Liters per hour
Geometric Coefficient of Variation 20.1
|
1.70 Liters per hour
Geometric Coefficient of Variation 20.1
|
2.38 Liters per hour
Geometric Coefficient of Variation 17.7
|
2.64 Liters per hour
Geometric Coefficient of Variation 16.9
|
1.79 Liters per hour
Geometric Coefficient of Variation 13.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 28: pre-dose, and at 1, 2, 4, 6, 8, and 12 hours post dosePopulation: Pharmacokinetic Population.
Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods.
Outcome measures
| Measure |
Part 2: Placebo (Pooled)
n=7 Participants
Participants were randomized to receive placebo in fasted state or in fed state with standard breakfast meal in capsule sizes matching MK-7762 100 mg and/or 300 mg.
|
Part 1: Cohort 1: SAD MK-7762 50 mg Fasted
n=7 Participants
Participants were randomized to receive a single dose of MK-7762 50 mg.
|
Part 1: Cohort 2: SAD MK-7762 150 mg Fasted
n=7 Participants
Participants were randomized to receive a single dose of MK-7762 150 mg.
|
Part 1: Cohort 3: SAD MK-7762 300 mg Fasted
n=7 Participants
Participants were randomized to receive a single dose of MK-7762 300 mg.
|
Part 1: Cohort 5: SAD MK-7762 1200 mg Fasted
n=7 Participants
Participants were randomized to receive a single dose of MK-7762 1200 mg.
|
Part 1: Placebo (Pooled)
n=7 Participants
Participants were randomized to receive a single dose of placebo in capsule sizes matching MK-7762 10 mg, 100 mg, and/or 300 mg.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fasted
Participants were administered a single dose of MK-7762 300 mg in fasted condition.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fed
Participants were administered a single dose of MK-7762 300 mg in fed condition.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: MAD Cohorts: Vz/F of MK-7762
|
61.4 Liters
Geometric Coefficient of Variation 19.5
|
62.4 Liters
Geometric Coefficient of Variation 31.1
|
64.4 Liters
Geometric Coefficient of Variation 13.8
|
83.7 Liters
Geometric Coefficient of Variation 12.4
|
90.5 Liters
Geometric Coefficient of Variation 30.8
|
62.4 Liters
Geometric Coefficient of Variation 14.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: predose and at 1, 2, 4, 6, 8, and 12 hours post dose; Day 28: pre-dose, and at 1, 2, 4, 6, 8, and 12 hours post dosePopulation: Pharmacokinetic Population.
Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. Accumulation ratio based on AUC 0-24 was calculated as AUC tau (Day 28) /AUC 0-24 (Day 1).
Outcome measures
| Measure |
Part 2: Placebo (Pooled)
n=7 Participants
Participants were randomized to receive placebo in fasted state or in fed state with standard breakfast meal in capsule sizes matching MK-7762 100 mg and/or 300 mg.
|
Part 1: Cohort 1: SAD MK-7762 50 mg Fasted
n=7 Participants
Participants were randomized to receive a single dose of MK-7762 50 mg.
|
Part 1: Cohort 2: SAD MK-7762 150 mg Fasted
n=7 Participants
Participants were randomized to receive a single dose of MK-7762 150 mg.
|
Part 1: Cohort 3: SAD MK-7762 300 mg Fasted
n=7 Participants
Participants were randomized to receive a single dose of MK-7762 300 mg.
|
Part 1: Cohort 5: SAD MK-7762 1200 mg Fasted
n=7 Participants
Participants were randomized to receive a single dose of MK-7762 1200 mg.
|
Part 1: Placebo (Pooled)
n=7 Participants
Participants were randomized to receive a single dose of placebo in capsule sizes matching MK-7762 10 mg, 100 mg, and/or 300 mg.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fasted
Participants were administered a single dose of MK-7762 300 mg in fasted condition.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fed
Participants were administered a single dose of MK-7762 300 mg in fed condition.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: MAD Cohorts: Accumulation Ratio (RA AUC0-24) of MK-7762
|
2.78 Ratio
Geometric Coefficient of Variation 25.0
|
2.63 Ratio
Geometric Coefficient of Variation 21.8
|
2.73 Ratio
Geometric Coefficient of Variation 16.3
|
3.73 Ratio
Geometric Coefficient of Variation 15.6
|
3.19 Ratio
Geometric Coefficient of Variation 37.1
|
2.54 Ratio
Geometric Coefficient of Variation 24.6
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: pre-dose and at 1, 2, 4, 6, 8, and 12 hours post dose; Day 28: pre-dose, and at 1, 2, 4, 6, 8, and 12 hours postdosePopulation: Pharmacokinetic Population.
Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods.
Outcome measures
| Measure |
Part 2: Placebo (Pooled)
n=8 Participants
Participants were randomized to receive placebo in fasted state or in fed state with standard breakfast meal in capsule sizes matching MK-7762 100 mg and/or 300 mg.
|
Part 1: Cohort 1: SAD MK-7762 50 mg Fasted
n=8 Participants
Participants were randomized to receive a single dose of MK-7762 50 mg.
|
Part 1: Cohort 2: SAD MK-7762 150 mg Fasted
n=8 Participants
Participants were randomized to receive a single dose of MK-7762 150 mg.
|
Part 1: Cohort 3: SAD MK-7762 300 mg Fasted
n=8 Participants
Participants were randomized to receive a single dose of MK-7762 300 mg.
|
Part 1: Cohort 5: SAD MK-7762 1200 mg Fasted
n=8 Participants
Participants were randomized to receive a single dose of MK-7762 1200 mg.
|
Part 1: Placebo (Pooled)
n=8 Participants
Participants were randomized to receive a single dose of placebo in capsule sizes matching MK-7762 10 mg, 100 mg, and/or 300 mg.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fasted
Participants were administered a single dose of MK-7762 300 mg in fasted condition.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fed
Participants were administered a single dose of MK-7762 300 mg in fed condition.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: MAD Cohorts: Cmax of MK-7762
|
3550 Nanograms per milliliter
Geometric Coefficient of Variation 25.2
|
1040 Nanograms per milliliter
Geometric Coefficient of Variation 22.5
|
1180 Nanograms per milliliter
Geometric Coefficient of Variation 14.8
|
1880 Nanograms per milliliter
Geometric Coefficient of Variation 21.3
|
3100 Nanograms per milliliter
Geometric Coefficient of Variation 31.8
|
5860 Nanograms per milliliter
Geometric Coefficient of Variation 32.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: pre-dose and at 1, 2, 4, 6, 8, and 12 hours post dose; Day 28: pre-dose, and at 1, 2, 4, 6, 8, and 12 hours postdosePopulation: Pharmacokinetic Population.
Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods.
Outcome measures
| Measure |
Part 2: Placebo (Pooled)
n=8 Participants
Participants were randomized to receive placebo in fasted state or in fed state with standard breakfast meal in capsule sizes matching MK-7762 100 mg and/or 300 mg.
|
Part 1: Cohort 1: SAD MK-7762 50 mg Fasted
n=8 Participants
Participants were randomized to receive a single dose of MK-7762 50 mg.
|
Part 1: Cohort 2: SAD MK-7762 150 mg Fasted
n=8 Participants
Participants were randomized to receive a single dose of MK-7762 150 mg.
|
Part 1: Cohort 3: SAD MK-7762 300 mg Fasted
n=8 Participants
Participants were randomized to receive a single dose of MK-7762 300 mg.
|
Part 1: Cohort 5: SAD MK-7762 1200 mg Fasted
n=8 Participants
Participants were randomized to receive a single dose of MK-7762 1200 mg.
|
Part 1: Placebo (Pooled)
n=8 Participants
Participants were randomized to receive a single dose of placebo in capsule sizes matching MK-7762 10 mg, 100 mg, and/or 300 mg.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fasted
Participants were administered a single dose of MK-7762 300 mg in fasted condition.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fed
Participants were administered a single dose of MK-7762 300 mg in fed condition.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: MAD Cohorts: Tmax of MK-7762
|
7.00 Hours
Interval 6.0 to 8.03
|
6.00 Hours
Interval 2.0 to 23.2
|
6.02 Hours
Interval 4.0 to 12.0
|
17.6 Hours
Interval 8.0 to 23.3
|
17.6 Hours
Interval 7.98 to 23.3
|
8.00 Hours
Interval 3.98 to 12.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 24 hours post dosePopulation: Pharmacokinetic Population.
Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods.
Outcome measures
| Measure |
Part 2: Placebo (Pooled)
n=8 Participants
Participants were randomized to receive placebo in fasted state or in fed state with standard breakfast meal in capsule sizes matching MK-7762 100 mg and/or 300 mg.
|
Part 1: Cohort 1: SAD MK-7762 50 mg Fasted
n=8 Participants
Participants were randomized to receive a single dose of MK-7762 50 mg.
|
Part 1: Cohort 2: SAD MK-7762 150 mg Fasted
n=8 Participants
Participants were randomized to receive a single dose of MK-7762 150 mg.
|
Part 1: Cohort 3: SAD MK-7762 300 mg Fasted
n=8 Participants
Participants were randomized to receive a single dose of MK-7762 300 mg.
|
Part 1: Cohort 5: SAD MK-7762 1200 mg Fasted
n=8 Participants
Participants were randomized to receive a single dose of MK-7762 1200 mg.
|
Part 1: Placebo (Pooled)
n=8 Participants
Participants were randomized to receive a single dose of placebo in capsule sizes matching MK-7762 10 mg, 100 mg, and/or 300 mg.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fasted
Participants were administered a single dose of MK-7762 300 mg in fasted condition.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fed
Participants were administered a single dose of MK-7762 300 mg in fed condition.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: MAD Cohorts: AUC0-24 of MK-7762
|
62000 Hours*nanograms per milliliter
Geometric Coefficient of Variation 21.2
|
20400 Hours*nanograms per milliliter
Geometric Coefficient of Variation 22.9
|
21000 Hours*nanograms per milliliter
Geometric Coefficient of Variation 14.8
|
35000 Hours*nanograms per milliliter
Geometric Coefficient of Variation 19.4
|
60200 Hours*nanograms per milliliter
Geometric Coefficient of Variation 33.3
|
107000 Hours*nanograms per milliliter
Geometric Coefficient of Variation 28.4
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 28: pre-dose, and at 1, 2, 4, 6, 8, and 12 hours postdosePopulation: Pharmacokinetic Population.
Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods.
Outcome measures
| Measure |
Part 2: Placebo (Pooled)
n=7 Participants
Participants were randomized to receive placebo in fasted state or in fed state with standard breakfast meal in capsule sizes matching MK-7762 100 mg and/or 300 mg.
|
Part 1: Cohort 1: SAD MK-7762 50 mg Fasted
n=7 Participants
Participants were randomized to receive a single dose of MK-7762 50 mg.
|
Part 1: Cohort 2: SAD MK-7762 150 mg Fasted
n=7 Participants
Participants were randomized to receive a single dose of MK-7762 150 mg.
|
Part 1: Cohort 3: SAD MK-7762 300 mg Fasted
n=7 Participants
Participants were randomized to receive a single dose of MK-7762 300 mg.
|
Part 1: Cohort 5: SAD MK-7762 1200 mg Fasted
n=7 Participants
Participants were randomized to receive a single dose of MK-7762 1200 mg.
|
Part 1: Placebo (Pooled)
n=7 Participants
Participants were randomized to receive a single dose of placebo in capsule sizes matching MK-7762 10 mg, 100 mg, and/or 300 mg.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fasted
Participants were administered a single dose of MK-7762 300 mg in fasted condition.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fed
Participants were administered a single dose of MK-7762 300 mg in fed condition.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: MAD Cohorts: AUClast of MK-7762
|
374000 Hours*nanograms per milliliter
Geometric Coefficient of Variation 32.6
|
108000 Hours*nanograms per milliliter
Geometric Coefficient of Variation 17.1
|
124000 Hours*nanograms per milliliter
Geometric Coefficient of Variation 32.3
|
324000 Hours*nanograms per milliliter
Geometric Coefficient of Variation 24.9
|
526000 Hours*nanograms per milliliter
Geometric Coefficient of Variation 27.1
|
653000 Hours*nanograms per milliliter
Geometric Coefficient of Variation 16.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 28: pre-dose, and at 1, 2, 4, 6, 8, and 12 hours post dosePopulation: Pharmacokinetic Population.
Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods.
Outcome measures
| Measure |
Part 2: Placebo (Pooled)
n=7 Participants
Participants were randomized to receive placebo in fasted state or in fed state with standard breakfast meal in capsule sizes matching MK-7762 100 mg and/or 300 mg.
|
Part 1: Cohort 1: SAD MK-7762 50 mg Fasted
n=7 Participants
Participants were randomized to receive a single dose of MK-7762 50 mg.
|
Part 1: Cohort 2: SAD MK-7762 150 mg Fasted
n=7 Participants
Participants were randomized to receive a single dose of MK-7762 150 mg.
|
Part 1: Cohort 3: SAD MK-7762 300 mg Fasted
n=7 Participants
Participants were randomized to receive a single dose of MK-7762 300 mg.
|
Part 1: Cohort 5: SAD MK-7762 1200 mg Fasted
n=7 Participants
Participants were randomized to receive a single dose of MK-7762 1200 mg.
|
Part 1: Placebo (Pooled)
n=7 Participants
Participants were randomized to receive a single dose of placebo in capsule sizes matching MK-7762 10 mg, 100 mg, and/or 300 mg.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fasted
Participants were administered a single dose of MK-7762 300 mg in fasted condition.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fed
Participants were administered a single dose of MK-7762 300 mg in fed condition.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: MAD Cohorts: AUC0-inf of MK-7762
|
377000 Hours*nanograms per milliliter
Geometric Coefficient of Variation 32.5
|
110000 Hours*nanograms per milliliter
Geometric Coefficient of Variation 16.5
|
127000 Hours*nanograms per milliliter
Geometric Coefficient of Variation 32.1
|
326000 Hours*nanograms per milliliter
Geometric Coefficient of Variation 24.9
|
532000 Hours*nanograms per milliliter
Geometric Coefficient of Variation 28.0
|
657000 Hours*nanograms per milliliter
Geometric Coefficient of Variation 16.4
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 28: pre-dose, and at 1, 2, 4, 6, 8, 12 and 24 hours postdosePopulation: Pharmacokinetic Population.
Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods.
Outcome measures
| Measure |
Part 2: Placebo (Pooled)
n=7 Participants
Participants were randomized to receive placebo in fasted state or in fed state with standard breakfast meal in capsule sizes matching MK-7762 100 mg and/or 300 mg.
|
Part 1: Cohort 1: SAD MK-7762 50 mg Fasted
n=7 Participants
Participants were randomized to receive a single dose of MK-7762 50 mg.
|
Part 1: Cohort 2: SAD MK-7762 150 mg Fasted
n=7 Participants
Participants were randomized to receive a single dose of MK-7762 150 mg.
|
Part 1: Cohort 3: SAD MK-7762 300 mg Fasted
n=7 Participants
Participants were randomized to receive a single dose of MK-7762 300 mg.
|
Part 1: Cohort 5: SAD MK-7762 1200 mg Fasted
n=7 Participants
Participants were randomized to receive a single dose of MK-7762 1200 mg.
|
Part 1: Placebo (Pooled)
n=7 Participants
Participants were randomized to receive a single dose of placebo in capsule sizes matching MK-7762 10 mg, 100 mg, and/or 300 mg.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fasted
Participants were administered a single dose of MK-7762 300 mg in fasted condition.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fed
Participants were administered a single dose of MK-7762 300 mg in fed condition.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: MAD Cohorts: AUC0-24 of MK-7762
|
169000 Hours*nanograms per milliliter
Geometric Coefficient of Variation 19.7
|
52600 Hours*nanograms per milliliter
Geometric Coefficient of Variation 20.1
|
58900 Hours*nanograms per milliliter
Geometric Coefficient of Variation 20.1
|
126000 Hours*nanograms per milliliter
Geometric Coefficient of Variation 17.7
|
189000 Hours*nanograms per milliliter
Geometric Coefficient of Variation 16.9
|
279000 Hours*nanograms per milliliter
Geometric Coefficient of Variation 13.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 28: pre-dose, and at 1, 2, 4, 6, 8, and 12 hours post dosePopulation: Pharmacokinetic Population.
Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods.
Outcome measures
| Measure |
Part 2: Placebo (Pooled)
n=7 Participants
Participants were randomized to receive placebo in fasted state or in fed state with standard breakfast meal in capsule sizes matching MK-7762 100 mg and/or 300 mg.
|
Part 1: Cohort 1: SAD MK-7762 50 mg Fasted
n=7 Participants
Participants were randomized to receive a single dose of MK-7762 50 mg.
|
Part 1: Cohort 2: SAD MK-7762 150 mg Fasted
n=7 Participants
Participants were randomized to receive a single dose of MK-7762 150 mg.
|
Part 1: Cohort 3: SAD MK-7762 300 mg Fasted
n=7 Participants
Participants were randomized to receive a single dose of MK-7762 300 mg.
|
Part 1: Cohort 5: SAD MK-7762 1200 mg Fasted
n=7 Participants
Participants were randomized to receive a single dose of MK-7762 1200 mg.
|
Part 1: Placebo (Pooled)
n=7 Participants
Participants were randomized to receive a single dose of placebo in capsule sizes matching MK-7762 10 mg, 100 mg, and/or 300 mg.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fasted
Participants were administered a single dose of MK-7762 300 mg in fasted condition.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fed
Participants were administered a single dose of MK-7762 300 mg in fed condition.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: MAD Cohorts: t1/2 of MK-7762
|
24.0 Hours
Geometric Coefficient of Variation 24.6
|
22.8 Hours
Geometric Coefficient of Variation 15.4
|
26.3 Hours
Geometric Coefficient of Variation 18.5
|
24.4 Hours
Geometric Coefficient of Variation 11.5
|
23.7 Hours
Geometric Coefficient of Variation 31.7
|
24.2 Hours
Geometric Coefficient of Variation 21.1
|
—
|
—
|
Adverse Events
Part 1: Cohort 1: SAD MK-7762 50 Milligrams (mg) Fasted
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 1: Cohort 2: SAD MK-7762 150 mg Fasted
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 1: Cohort 3: SAD MK-7762 300 mg Fasted
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 1: Cohort 4: SAD MK-7762 600 mg Fasted
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 1: Cohort 5: SAD MK-7762 1200 mg Fasted
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 1: Placebo (Pooled)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1: Cohort 6: FE MK-7762 300 mg Fasted
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 1: Cohort 6: FE MK-7762 300 mg Fed
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 2: Cohort 7: FE 600 mg Fasted
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 2: Cohort 7: FE 600 mg Fed-Standard Meal
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 2: Cohort 7: FE 600 mg Fed High-fat Meal
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 2: Cohort 8: MAD MK-7762 100 mg
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Part 2: Cohort 9: MAD MK-7762 300 mg
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Part 2: Cohort 10: MAD MK-7762 500 mg
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Part 2: Placebo (Pooled)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 1: Cohort 1: SAD MK-7762 50 Milligrams (mg) Fasted
n=6 participants at risk
Participants were randomized to receive a single dose of MK-7762 50 mg.
|
Part 1: Cohort 2: SAD MK-7762 150 mg Fasted
n=6 participants at risk
Participants were randomized to receive a single dose of MK-7762 150 mg.
|
Part 1: Cohort 3: SAD MK-7762 300 mg Fasted
n=6 participants at risk
Participants were randomized to receive a single dose of MK-7762 300 mg.
|
Part 1: Cohort 4: SAD MK-7762 600 mg Fasted
n=6 participants at risk
Participants were randomized to receive a single dose of MK-7762 600 mg.
|
Part 1: Cohort 5: SAD MK-7762 1200 mg Fasted
n=6 participants at risk
Participants were randomized to receive a single dose of MK-7762 1200 mg.
|
Part 1: Placebo (Pooled)
n=10 participants at risk
Participants were randomized to receive a single dose of placebo in capsule sizes matching MK-7762 10 mg, 100 mg, and/or 300 mg.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fasted
n=8 participants at risk
Participants were administered a single dose of MK-7762 300 mg in fasted condition.
|
Part 1: Cohort 6: FE MK-7762 300 mg Fed
n=8 participants at risk
Participants were administered a single dose of MK-7762 300 mg in fed condition.
|
Part 2: Cohort 7: FE 600 mg Fasted
n=10 participants at risk
Participants were administered with 600 mg MK-7762 in a fasted state.
|
Part 2: Cohort 7: FE 600 mg Fed-Standard Meal
n=10 participants at risk
Participants were administered with 600 mg MK-7762 after a standard meal breakfast.
|
Part 2: Cohort 7: FE 600 mg Fed High-fat Meal
n=9 participants at risk
Participants were administered with 600 mg MK-7762 after a high-fat meal breakfast.
|
Part 2: Cohort 8: MAD MK-7762 100 mg
n=16 participants at risk
Participants were randomized to receive MK-7762 100 mg in a fed or fasted state.
|
Part 2: Cohort 9: MAD MK-7762 300 mg
n=16 participants at risk
Participants were randomized to receive MK-7762 300 mg in a fed or fasted state.
|
Part 2: Cohort 10: MAD MK-7762 500 mg
n=16 participants at risk
Participants were randomized to receive MK-7762 500 mg in a fed or fasted state.
|
Part 2: Placebo (Pooled)
n=12 participants at risk
Participants were randomized to receive placebo in fasted state or in fed state with standard breakfast meal in capsule sizes matching MK-7762 100 mg and/or 300 mg.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/10 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/5 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
6.2%
1/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
8.3%
1/12 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
|
Eye disorders
Dry Eye
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/10 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/5 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
6.2%
1/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
6.2%
1/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/12 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
|
Eye disorders
Ocular Discomfort
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/10 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/5 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
6.2%
1/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/12 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
|
Eye disorders
Vision Blurred
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/10 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/5 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
6.2%
1/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
8.3%
1/12 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
|
Eye disorders
Vitreous Floaters
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
10.0%
1/10 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/5 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
6.2%
1/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/12 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/10 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
20.0%
1/5 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
8.3%
1/12 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/10 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/5 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
12.5%
2/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/12 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/10 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/5 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
6.2%
1/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/12 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/10 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/5 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
6.2%
1/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/12 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
|
Gastrointestinal disorders
Aphthous Ulcer
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/10 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/5 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
6.2%
1/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/12 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/10 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/5 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
25.0%
1/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/12 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/10 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/5 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
6.2%
1/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
16.7%
2/12 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/10 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/5 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
6.2%
1/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
6.2%
1/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/12 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/10 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/5 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
12.5%
2/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/12 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
|
Gastrointestinal disorders
Hypertrophy Of Tongue Papillae
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/10 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/5 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
6.2%
1/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/12 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/10 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/5 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
25.0%
1/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/12 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
|
Gastrointestinal disorders
Paraesthesia Oral
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/10 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/5 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
6.2%
1/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/12 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/10 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/5 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
6.2%
1/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/12 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
16.7%
1/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/10 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/5 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/12 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
16.7%
1/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/10 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/5 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/12 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
|
General disorders
Chest Discomfort
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/10 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/5 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
6.2%
1/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/12 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
|
General disorders
Fatigue
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/10 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/5 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
25.0%
1/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
25.0%
1/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
33.3%
1/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
6.2%
1/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/12 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
|
General disorders
Medical Device Site Reaction
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/10 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/5 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
25.0%
1/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
25.0%
1/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
33.3%
1/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
12.5%
2/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
12.5%
2/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
8.3%
1/12 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
|
General disorders
Nodule
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/10 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/5 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
6.2%
1/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/12 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
|
General disorders
Sensation Of Foreign Body
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/10 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/5 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
6.2%
1/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/12 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
|
General disorders
Thirst Decreased
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/10 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/5 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/12 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
|
Infections and infestations
COVID-19
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/10 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/5 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
25.0%
1/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
25.0%
1/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
6.2%
1/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/12 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
|
Infections and infestations
Cystitis
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/10 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/5 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
6.2%
1/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/12 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
10.0%
1/10 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/5 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/12 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/10 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/5 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
6.2%
1/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/12 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/10 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/5 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
6.2%
1/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
8.3%
1/12 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
|
Investigations
Weight Decreased
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/10 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/5 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
50.0%
8/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
25.0%
4/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
43.8%
7/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
16.7%
2/12 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/10 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/5 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/12 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
|
Metabolism and nutrition disorders
Metabolic Acidosis
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/10 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/5 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
6.2%
1/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/12 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/10 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/5 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
8.3%
1/12 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
16.7%
1/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/10 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/5 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
12.5%
2/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
6.2%
1/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/12 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/10 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/5 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
12.5%
2/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/12 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
|
Musculoskeletal and connective tissue disorders
Muscle Tightness
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/10 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/5 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
6.2%
1/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/12 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
|
Musculoskeletal and connective tissue disorders
Muscle Twitching
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/10 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/5 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
6.2%
1/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/12 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/10 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/5 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
6.2%
1/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/12 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/10 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/5 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
6.2%
1/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/12 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/10 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/5 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
6.2%
1/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
6.2%
1/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/12 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
|
Nervous system disorders
Decreased Vibratory Sense
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/10 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/5 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
6.2%
1/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
6.2%
1/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/12 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/10 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/5 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
6.2%
1/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/12 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/10 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/5 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
6.2%
1/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/12 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/10 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/5 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
50.0%
2/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
50.0%
2/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
100.0%
3/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/12 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/10 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/5 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
8.3%
1/12 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/10 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/5 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
6.2%
1/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/12 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
|
Reproductive system and breast disorders
Intermenstrual Bleeding
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/10 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/5 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
6.2%
1/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/12 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
|
Reproductive system and breast disorders
Nipple Pain
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/10 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/5 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
8.3%
1/12 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/10 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/5 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/12 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/10 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/5 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
25.0%
1/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/12 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Dryness
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/10 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/5 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/12 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/10 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/5 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/12 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/10 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/5 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/12 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/10 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/5 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
25.0%
1/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/12 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/10 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/5 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/12 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
|
Skin and subcutaneous tissue disorders
Nail Cuticle Fissure
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/10 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/5 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/12 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/6 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/10 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/5 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/4 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/3 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/16 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
0.00%
0/12 • Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER