Trial Outcomes & Findings for A Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability of TAK-788 Followed by Evaluation of the Effects of a Low-Fat Meal on TAK-788 PK and Evaluation of Relative Bioavailability of TAK-788 Capsules in Healthy Participants (NCT NCT03482453)
NCT ID: NCT03482453
Last Updated: 2020-01-29
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
69 participants
Primary outcome timeframe
Baseline up to 30 days after the last dose of study drug (Day 31)
Results posted on
2020-01-29
Participant Flow
Participants took part in the study at 1 investigative site in the United States from 28 March 2018 to 18 January 2019.
Healthy participants were enrolled in this 3 parts study to receive: TAK-788 as a single rising dose of 20 milligram (mg), 40 mg, 80 mg, 120 mg, 160 mg in Part 1; TAK-788 in a 2-way cross-over design with or without a low-fat meal in Part B; or in a 2-way cross-over sequence to receive TAK-788 drug in capsule (DiC) A or B in Part 3.
Participant milestones
| Measure |
Part 1: Pooled Placebo
TAK-788 matching placebo capsule, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 1: TAK-788 20 mg
TAK-788 20 mg, capsule, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 2: TAK-788 40 mg
TAK-788 40 mg, capsule, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 3: TAK-788 80 mg
TAK-788 80 mg, capsule, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 4: TAK-788 120 mg
TAK-788 120 mg, capsule, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 5: TAK-788 160 mg
TAK-788 160 mg, capsule, orally, once under fasted conditions on Day 1.
|
Part 2: TAK-788 120 mg Fed + TAK-788 120 mg Fasted
TAK-788 120 mg, capsule, orally, once on Day 1 of Intervention Period 1 under fed conditions with low-fat meal (Treatment A), followed by at least 7 days washout period, further followed by TAK-788, 120 mg, capsule, orally, once on Day 1 of Intervention Period 2 under fasted conditions (Treatment B).
|
Part 2: TAK-788 120 mg Fasted + TAK-788 120 mg Fed
TAK-788, 120 mg, capsule, orally, once on Day 1 of Intervention Period 1 under fasted conditions (Treatment B), followed by at least 7 days washout period, further followed by TAK-788, 120 mg, capsule, orally, once on Day 1 of Intervention Period 2 under fed conditions with low-fat meal (Treatment A).
|
Part 2: TAK-788 160 mg Fed + TAK-788 160 mg Fasted
TAK-788 160 mg, capsule, orally, once on Day 1 of Intervention Period 1 under fed conditions with low-fat meal (Treatment A), followed by at least 7 days washout period, further followed by TAK-788 160 mg, capsule, orally, once on Day 1 of Intervention Period 2 under fasted conditions (Treatment B).
|
Part 2: TAK-788 160 mg Fasted + TAK-788 160 mg Fed
TAK-788, 160 mg, capsule, orally, once on Day 1 of Intervention Period 1 under fasted conditions (Treatment B), followed by at least 7 days washout period, further followed by TAK-788, 160 mg, capsule, orally, once on Day 1 of Intervention Period 2 under fed conditions with low-fat meal (Treatment A).
|
Part 3: TAK-788 DiC A + TAK-788 DiC B
TAK-7 160 mg, DiC A (reference), orally, under fasted condition, once on Day 1 of Intervention Period 1, followed by at least 7 days washout period, further followed by TAK-788 160 mg, DiC B (test), orally, under fasted condition, once on Day 1 of Intervention Period 2.
|
Part 3: TAK-788 DiC B + TAK-788 DiC A
TAK-788 160 mg, DiC B (test), orally, under fasted condition, once on Day 1 of Intervention Period 1, followed by at least 7 days washout period, further followed by TAK-788 160 mg, DiC A (reference), orally, under fasted condition, once on Day 1 of Intervention Period 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1 (1 Day)
STARTED
|
10
|
6
|
6
|
6
|
6
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1 (1 Day)
COMPLETED
|
10
|
6
|
6
|
6
|
6
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1 (1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Parts 2, 3 Intervention Period 1 (1 Day)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
3
|
5
|
5
|
7
|
6
|
|
Parts 2, 3 Intervention Period 1 (1 Day)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
3
|
5
|
5
|
6
|
6
|
|
Parts 2, 3 Intervention Period 1 (1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Parts 2, 3 Washout Period (7 Days)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
3
|
5
|
5
|
6
|
6
|
|
Parts 2, 3 Washout Period (7 Days)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
3
|
5
|
5
|
6
|
6
|
|
Parts 2, 3 Washout Period (7 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Parts 2, 3 Intervention Period 2 (1 Day)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
3
|
5
|
5
|
6
|
6
|
|
Parts 2, 3 Intervention Period 2 (1 Day)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
3
|
5
|
5
|
6
|
6
|
|
Parts 2, 3 Intervention Period 2 (1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Part 1: Pooled Placebo
TAK-788 matching placebo capsule, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 1: TAK-788 20 mg
TAK-788 20 mg, capsule, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 2: TAK-788 40 mg
TAK-788 40 mg, capsule, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 3: TAK-788 80 mg
TAK-788 80 mg, capsule, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 4: TAK-788 120 mg
TAK-788 120 mg, capsule, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 5: TAK-788 160 mg
TAK-788 160 mg, capsule, orally, once under fasted conditions on Day 1.
|
Part 2: TAK-788 120 mg Fed + TAK-788 120 mg Fasted
TAK-788 120 mg, capsule, orally, once on Day 1 of Intervention Period 1 under fed conditions with low-fat meal (Treatment A), followed by at least 7 days washout period, further followed by TAK-788, 120 mg, capsule, orally, once on Day 1 of Intervention Period 2 under fasted conditions (Treatment B).
|
Part 2: TAK-788 120 mg Fasted + TAK-788 120 mg Fed
TAK-788, 120 mg, capsule, orally, once on Day 1 of Intervention Period 1 under fasted conditions (Treatment B), followed by at least 7 days washout period, further followed by TAK-788, 120 mg, capsule, orally, once on Day 1 of Intervention Period 2 under fed conditions with low-fat meal (Treatment A).
|
Part 2: TAK-788 160 mg Fed + TAK-788 160 mg Fasted
TAK-788 160 mg, capsule, orally, once on Day 1 of Intervention Period 1 under fed conditions with low-fat meal (Treatment A), followed by at least 7 days washout period, further followed by TAK-788 160 mg, capsule, orally, once on Day 1 of Intervention Period 2 under fasted conditions (Treatment B).
|
Part 2: TAK-788 160 mg Fasted + TAK-788 160 mg Fed
TAK-788, 160 mg, capsule, orally, once on Day 1 of Intervention Period 1 under fasted conditions (Treatment B), followed by at least 7 days washout period, further followed by TAK-788, 160 mg, capsule, orally, once on Day 1 of Intervention Period 2 under fed conditions with low-fat meal (Treatment A).
|
Part 3: TAK-788 DiC A + TAK-788 DiC B
TAK-7 160 mg, DiC A (reference), orally, under fasted condition, once on Day 1 of Intervention Period 1, followed by at least 7 days washout period, further followed by TAK-788 160 mg, DiC B (test), orally, under fasted condition, once on Day 1 of Intervention Period 2.
|
Part 3: TAK-788 DiC B + TAK-788 DiC A
TAK-788 160 mg, DiC B (test), orally, under fasted condition, once on Day 1 of Intervention Period 1, followed by at least 7 days washout period, further followed by TAK-788 160 mg, DiC A (reference), orally, under fasted condition, once on Day 1 of Intervention Period 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Parts 2, 3 Intervention Period 1 (1 Day)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability of TAK-788 Followed by Evaluation of the Effects of a Low-Fat Meal on TAK-788 PK and Evaluation of Relative Bioavailability of TAK-788 Capsules in Healthy Participants
Baseline characteristics by cohort
| Measure |
Part 1: Pooled Placebo
n=10 Participants
TAK-788 matching placebo capsule, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 1: TAK-788 20 mg
n=6 Participants
TAK-788 20 mg, capsule, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 2: TAK-788 40 mg
n=6 Participants
TAK-788 40 mg, capsule, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 3: TAK-788 80 mg
n=6 Participants
TAK-788 80 mg, capsule, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 4: TAK-788 120 mg
n=6 Participants
TAK-788 120 mg, capsule, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 5: TAK-788 160 mg
n=6 Participants
TAK-788 160 mg, capsule, orally, once under fasted conditions on Day 1.
|
Part 2: TAK-788 120 mg Fed + TAK-788 120 mg Fasted
n=3 Participants
TAK-788 120 mg, capsule, orally, once on Day 1 of Intervention Period 1 under fed conditions with low-fat meal (Treatment A), followed by at least 7 days washout period, further followed by TAK-788, 120 mg, capsule, orally, once on Day 1 of Intervention Period 2 under fasted conditions (Treatment B).
|
Part 2: TAK-788 120 mg Fasted + TAK-788 120 mg Fed
n=3 Participants
TAK-788, 120 mg, capsule, orally, once on Day 1 of Intervention Period 1 under fasted conditions (Treatment B), followed by at least 7 days washout period, further followed by TAK-788, 120 mg, capsule, orally, once on Day 1 of Intervention Period 2 under fed conditions with low-fat meal (Treatment A).
|
Part 2: TAK-788 160 mg Fed + TAK-788 160 mg Fasted
n=5 Participants
TAK-788 160 mg, capsule, orally, once on Day 1 of Intervention Period 1 under fed conditions with low-fat meal (Treatment A), followed by at least 7 days washout period, further followed by TAK-788 160 mg, capsule, orally, once on Day 1 of Intervention Period 2 under fasted conditions (Treatment B).
|
Part 2: TAK-788 160 mg Fasted + TAK-788 160 mg Fed
n=5 Participants
TAK-788, 160 mg, capsule, orally, once on Day 1 of Intervention Period 1 under fasted conditions (Treatment B), followed by at least 7 days washout period, further followed by TAK-788, 160 mg, capsule, orally, once on Day 1 of Intervention Period 2 under fed conditions with low-fat meal (Treatment A).
|
Part 3: TAK-788 DiC A + TAK-788 DiC B
n=7 Participants
TAK-7 160 mg, DiC A (reference), orally, under fasted condition, once on Day 1 of Intervention Period 1, followed by at least 7 days washout period, further followed by TAK-788 160 mg, DiC B (test), orally, under fasted condition, once on Day 1 of Intervention Period 2.
|
Part 3: TAK-788 DiC B + TAK-788 DiC A
n=6 Participants
TAK-788 160 mg, DiC B (test), orally, under fasted condition, once on Day 1 of Intervention Period 1, followed by at least 7 days washout period, further followed by TAK-788 160 mg, DiC A (reference), orally, under fasted condition, once on Day 1 of Intervention Period 2.
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
5 Participants
n=114 Participants
|
5 Participants
|
7 Participants
n=19 Participants
|
6 Participants
n=4 Participants
|
69 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
1 Participants
|
2 Participants
n=19 Participants
|
1 Participants
n=4 Participants
|
17 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
5 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
4 Participants
n=114 Participants
|
4 Participants
|
5 Participants
n=19 Participants
|
5 Participants
n=4 Participants
|
52 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
0 Participants
|
2 Participants
n=19 Participants
|
2 Participants
n=4 Participants
|
10 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
4 Participants
n=114 Participants
|
5 Participants
|
5 Participants
n=19 Participants
|
4 Participants
n=4 Participants
|
59 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
1 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
5 Participants
n=114 Participants
|
4 Participants
|
7 Participants
n=19 Participants
|
5 Participants
n=4 Participants
|
66 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
5 Participants
n=114 Participants
|
5 Participants
|
7 Participants
n=19 Participants
|
6 Participants
n=4 Participants
|
69 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 30 days after the last dose of study drug (Day 31)Population: The safety set included all participants who received any study treatment.
Outcome measures
| Measure |
Part 2: TAK-788 160 mg Fasted
n=6 Participants
TAK-788, 160 mg, capsule, orally, under fasted conditions (Treatment B), once on Day 1 of either Intervention Period 1 or 2.
|
Part 3: TAK-788 160 mg DiC A
n=6 Participants
TAK-788 160 mg, DiC A (reference), orally, under fasted condition, once on Day 1 of Intervention Period 1.
|
Part 3: TAK-788 160 mg DiC B
n=6 Participants
TAK-788 160 mg, DiC B (test), orally, under fasted condition, once, on Day 1 of Intervention Period 1.
|
Part 2: TAK-788 120 mg Fed
n=10 Participants
TAK-788 120 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
|
Part 2: TAK-788 120 mg Fasted
n=6 Participants
TAK-788, 120 mg, capsule, orally, once on Day 1 of Intervention Period 1 under fasted conditions (Treatment B).
|
Part 2: TAK-788 160 mg Fed
n=6 Participants
TAK-788, 160 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
|
|---|---|---|---|---|---|---|
|
Part 1: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
|
4 Participants
|
3 Participants
|
5 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 30 days after the last dose of study drug (Day 31)Population: The safety set included all participants who received any study treatment.
Outcome measures
| Measure |
Part 2: TAK-788 160 mg Fasted
n=6 Participants
TAK-788, 160 mg, capsule, orally, under fasted conditions (Treatment B), once on Day 1 of either Intervention Period 1 or 2.
|
Part 3: TAK-788 160 mg DiC A
n=6 Participants
TAK-788 160 mg, DiC A (reference), orally, under fasted condition, once on Day 1 of Intervention Period 1.
|
Part 3: TAK-788 160 mg DiC B
n=6 Participants
TAK-788 160 mg, DiC B (test), orally, under fasted condition, once, on Day 1 of Intervention Period 1.
|
Part 2: TAK-788 120 mg Fed
n=10 Participants
TAK-788 120 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
|
Part 2: TAK-788 120 mg Fasted
n=6 Participants
TAK-788, 120 mg, capsule, orally, once on Day 1 of Intervention Period 1 under fasted conditions (Treatment B).
|
Part 2: TAK-788 160 mg Fed
n=6 Participants
TAK-788, 160 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
|
|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With One or More Serious Adverse Events (SAEs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 30 days after the last dose of study drug (Day 31)Population: The safety set included all participants who received any study treatment.
Outcome measures
| Measure |
Part 2: TAK-788 160 mg Fasted
n=6 Participants
TAK-788, 160 mg, capsule, orally, under fasted conditions (Treatment B), once on Day 1 of either Intervention Period 1 or 2.
|
Part 3: TAK-788 160 mg DiC A
n=6 Participants
TAK-788 160 mg, DiC A (reference), orally, under fasted condition, once on Day 1 of Intervention Period 1.
|
Part 3: TAK-788 160 mg DiC B
n=6 Participants
TAK-788 160 mg, DiC B (test), orally, under fasted condition, once, on Day 1 of Intervention Period 1.
|
Part 2: TAK-788 120 mg Fed
n=10 Participants
TAK-788 120 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
|
Part 2: TAK-788 120 mg Fasted
n=6 Participants
TAK-788, 120 mg, capsule, orally, once on Day 1 of Intervention Period 1 under fasted conditions (Treatment B).
|
Part 2: TAK-788 160 mg Fed
n=6 Participants
TAK-788, 160 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
|
|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Clinically Significant Abnormal Laboratory Values
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 30 days after the last dose of study drug (Day 31)Population: The safety set included all participants who received any study treatment.
Outcome measures
| Measure |
Part 2: TAK-788 160 mg Fasted
n=6 Participants
TAK-788, 160 mg, capsule, orally, under fasted conditions (Treatment B), once on Day 1 of either Intervention Period 1 or 2.
|
Part 3: TAK-788 160 mg DiC A
n=6 Participants
TAK-788 160 mg, DiC A (reference), orally, under fasted condition, once on Day 1 of Intervention Period 1.
|
Part 3: TAK-788 160 mg DiC B
n=6 Participants
TAK-788 160 mg, DiC B (test), orally, under fasted condition, once, on Day 1 of Intervention Period 1.
|
Part 2: TAK-788 120 mg Fed
n=10 Participants
TAK-788 120 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
|
Part 2: TAK-788 120 mg Fasted
n=6 Participants
TAK-788, 120 mg, capsule, orally, once on Day 1 of Intervention Period 1 under fasted conditions (Treatment B).
|
Part 2: TAK-788 160 mg Fed
n=6 Participants
TAK-788, 160 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
|
|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Clinically Significant Abnormal Vital Signs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dosePopulation: The pharmacokinetic (PK) set included all participants in the safety set who had no major protocol deviations that would have affected the PK analysis and who had sufficient data to calculate PK parameters.
Outcome measures
| Measure |
Part 2: TAK-788 160 mg Fasted
n=10 Participants
TAK-788, 160 mg, capsule, orally, under fasted conditions (Treatment B), once on Day 1 of either Intervention Period 1 or 2.
|
Part 3: TAK-788 160 mg DiC A
TAK-788 160 mg, DiC A (reference), orally, under fasted condition, once on Day 1 of Intervention Period 1.
|
Part 3: TAK-788 160 mg DiC B
TAK-788 160 mg, DiC B (test), orally, under fasted condition, once, on Day 1 of Intervention Period 1.
|
Part 2: TAK-788 120 mg Fed
n=6 Participants
TAK-788 120 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
|
Part 2: TAK-788 120 mg Fasted
n=6 Participants
TAK-788, 120 mg, capsule, orally, once on Day 1 of Intervention Period 1 under fasted conditions (Treatment B).
|
Part 2: TAK-788 160 mg Fed
n=10 Participants
TAK-788, 160 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
|
|---|---|---|---|---|---|---|
|
Part 2, Cmax: Maximum Observed Plasma Concentration for TAK-788
|
41.00 nanogram per milliliter (ng/mL)
Standard Deviation 21.917
|
—
|
—
|
27.52 nanogram per milliliter (ng/mL)
Standard Deviation 11.423
|
31.24 nanogram per milliliter (ng/mL)
Standard Deviation 16.682
|
39.51 nanogram per milliliter (ng/mL)
Standard Deviation 17.179
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dosePopulation: The PK set included all participants in the safety set who had no major protocol deviations that would have affected the PK analysis and who had sufficient data to calculate PK parameters.
Outcome measures
| Measure |
Part 2: TAK-788 160 mg Fasted
TAK-788, 160 mg, capsule, orally, under fasted conditions (Treatment B), once on Day 1 of either Intervention Period 1 or 2.
|
Part 3: TAK-788 160 mg DiC A
TAK-788 160 mg, DiC A (reference), orally, under fasted condition, once on Day 1 of Intervention Period 1.
|
Part 3: TAK-788 160 mg DiC B
TAK-788 160 mg, DiC B (test), orally, under fasted condition, once, on Day 1 of Intervention Period 1.
|
Part 2: TAK-788 120 mg Fed
n=12 Participants
TAK-788 120 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
|
Part 2: TAK-788 120 mg Fasted
n=12 Participants
TAK-788, 120 mg, capsule, orally, once on Day 1 of Intervention Period 1 under fasted conditions (Treatment B).
|
Part 2: TAK-788 160 mg Fed
TAK-788, 160 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
|
|---|---|---|---|---|---|---|
|
Part 3, Cmax: Maximum Observed Plasma Concentration for TAK-788
|
—
|
—
|
—
|
44.77 ng/mL
Standard Deviation 14.738
|
41.71 ng/mL
Standard Deviation 11.931
|
—
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dosePopulation: The PK set included all participants in the safety set who had no major protocol deviations that would have affected the PK analysis and who had sufficient data to calculate PK parameters.
Outcome measures
| Measure |
Part 2: TAK-788 160 mg Fasted
n=10 Participants
TAK-788, 160 mg, capsule, orally, under fasted conditions (Treatment B), once on Day 1 of either Intervention Period 1 or 2.
|
Part 3: TAK-788 160 mg DiC A
TAK-788 160 mg, DiC A (reference), orally, under fasted condition, once on Day 1 of Intervention Period 1.
|
Part 3: TAK-788 160 mg DiC B
TAK-788 160 mg, DiC B (test), orally, under fasted condition, once, on Day 1 of Intervention Period 1.
|
Part 2: TAK-788 120 mg Fed
n=6 Participants
TAK-788 120 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
|
Part 2: TAK-788 120 mg Fasted
n=6 Participants
TAK-788, 120 mg, capsule, orally, once on Day 1 of Intervention Period 1 under fasted conditions (Treatment B).
|
Part 2: TAK-788 160 mg Fed
n=10 Participants
TAK-788, 160 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
|
|---|---|---|---|---|---|---|
|
Part 2, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-788
|
6.0 hour
Interval 2.0 to 12.0
|
—
|
—
|
6.0 hour
Interval 4.0 to 8.0
|
4.0 hour
Interval 2.0 to 6.0
|
6.0 hour
Interval 2.0 to 8.0
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dosePopulation: The PK set included all participants in the safety set who had no major protocol deviations that would have affected the PK analysis and who had sufficient data to calculate PK parameters.
Outcome measures
| Measure |
Part 2: TAK-788 160 mg Fasted
TAK-788, 160 mg, capsule, orally, under fasted conditions (Treatment B), once on Day 1 of either Intervention Period 1 or 2.
|
Part 3: TAK-788 160 mg DiC A
TAK-788 160 mg, DiC A (reference), orally, under fasted condition, once on Day 1 of Intervention Period 1.
|
Part 3: TAK-788 160 mg DiC B
TAK-788 160 mg, DiC B (test), orally, under fasted condition, once, on Day 1 of Intervention Period 1.
|
Part 2: TAK-788 120 mg Fed
n=12 Participants
TAK-788 120 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
|
Part 2: TAK-788 120 mg Fasted
n=12 Participants
TAK-788, 120 mg, capsule, orally, once on Day 1 of Intervention Period 1 under fasted conditions (Treatment B).
|
Part 2: TAK-788 160 mg Fed
TAK-788, 160 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
|
|---|---|---|---|---|---|---|
|
Part 3, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-788
|
—
|
—
|
—
|
6.0 hour
Interval 2.0 to 8.0
|
5.0 hour
Interval 2.0 to 8.0
|
—
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dosePopulation: The PK set included all participants in the safety set who had no major protocol deviations that would have affected the PK analysis and who had sufficient data to calculate PK parameters.
Outcome measures
| Measure |
Part 2: TAK-788 160 mg Fasted
n=10 Participants
TAK-788, 160 mg, capsule, orally, under fasted conditions (Treatment B), once on Day 1 of either Intervention Period 1 or 2.
|
Part 3: TAK-788 160 mg DiC A
TAK-788 160 mg, DiC A (reference), orally, under fasted condition, once on Day 1 of Intervention Period 1.
|
Part 3: TAK-788 160 mg DiC B
TAK-788 160 mg, DiC B (test), orally, under fasted condition, once, on Day 1 of Intervention Period 1.
|
Part 2: TAK-788 120 mg Fed
n=6 Participants
TAK-788 120 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
|
Part 2: TAK-788 120 mg Fasted
n=6 Participants
TAK-788, 120 mg, capsule, orally, once on Day 1 of Intervention Period 1 under fasted conditions (Treatment B).
|
Part 2: TAK-788 160 mg Fed
n=10 Participants
TAK-788, 160 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
|
|---|---|---|---|---|---|---|
|
Part 2, AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for TAK-788
|
733.6 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 461.41
|
—
|
—
|
526.3 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 272.72
|
518.3 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 300.84
|
700.6 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 295.10
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dosePopulation: The PK set included all participants in the safety set who had no major protocol deviations that would have affected the PK analysis and who had sufficient data to calculate PK parameters.
Outcome measures
| Measure |
Part 2: TAK-788 160 mg Fasted
TAK-788, 160 mg, capsule, orally, under fasted conditions (Treatment B), once on Day 1 of either Intervention Period 1 or 2.
|
Part 3: TAK-788 160 mg DiC A
TAK-788 160 mg, DiC A (reference), orally, under fasted condition, once on Day 1 of Intervention Period 1.
|
Part 3: TAK-788 160 mg DiC B
TAK-788 160 mg, DiC B (test), orally, under fasted condition, once, on Day 1 of Intervention Period 1.
|
Part 2: TAK-788 120 mg Fed
n=12 Participants
TAK-788 120 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
|
Part 2: TAK-788 120 mg Fasted
n=12 Participants
TAK-788, 120 mg, capsule, orally, once on Day 1 of Intervention Period 1 under fasted conditions (Treatment B).
|
Part 2: TAK-788 160 mg Fed
TAK-788, 160 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
|
|---|---|---|---|---|---|---|
|
Part 3, AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for TAK-788
|
—
|
—
|
—
|
706.1 h*ng/mL
Standard Deviation 173.63
|
677.9 h*ng/mL
Standard Deviation 239.28
|
—
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dosePopulation: The PK set included all participants in the safety set who had no major protocol deviations that would have affected the PK analysis and who had sufficient data to calculate PK parameters.
Outcome measures
| Measure |
Part 2: TAK-788 160 mg Fasted
n=10 Participants
TAK-788, 160 mg, capsule, orally, under fasted conditions (Treatment B), once on Day 1 of either Intervention Period 1 or 2.
|
Part 3: TAK-788 160 mg DiC A
TAK-788 160 mg, DiC A (reference), orally, under fasted condition, once on Day 1 of Intervention Period 1.
|
Part 3: TAK-788 160 mg DiC B
TAK-788 160 mg, DiC B (test), orally, under fasted condition, once, on Day 1 of Intervention Period 1.
|
Part 2: TAK-788 120 mg Fed
n=6 Participants
TAK-788 120 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
|
Part 2: TAK-788 120 mg Fasted
n=6 Participants
TAK-788, 120 mg, capsule, orally, once on Day 1 of Intervention Period 1 under fasted conditions (Treatment B).
|
Part 2: TAK-788 160 mg Fed
n=10 Participants
TAK-788, 160 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
|
|---|---|---|---|---|---|---|
|
Part 2, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-788
|
743.0 h*ng/mL
Standard Deviation 462.07
|
—
|
—
|
533.8 h*ng/mL
Standard Deviation 272.07
|
525.8 h*ng/mL
Standard Deviation 301.84
|
706.3 h*ng/mL
Standard Deviation 294.61
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dosePopulation: The PK set included all participants in the safety set who had no major protocol deviations that would have affected the PK analysis and who had sufficient data to calculate PK parameters.
Outcome measures
| Measure |
Part 2: TAK-788 160 mg Fasted
TAK-788, 160 mg, capsule, orally, under fasted conditions (Treatment B), once on Day 1 of either Intervention Period 1 or 2.
|
Part 3: TAK-788 160 mg DiC A
TAK-788 160 mg, DiC A (reference), orally, under fasted condition, once on Day 1 of Intervention Period 1.
|
Part 3: TAK-788 160 mg DiC B
TAK-788 160 mg, DiC B (test), orally, under fasted condition, once, on Day 1 of Intervention Period 1.
|
Part 2: TAK-788 120 mg Fed
n=12 Participants
TAK-788 120 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
|
Part 2: TAK-788 120 mg Fasted
n=12 Participants
TAK-788, 120 mg, capsule, orally, once on Day 1 of Intervention Period 1 under fasted conditions (Treatment B).
|
Part 2: TAK-788 160 mg Fed
TAK-788, 160 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
|
|---|---|---|---|---|---|---|
|
Part 3, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-788
|
—
|
—
|
—
|
738.8 h*ng/mL
Standard Deviation 193.06
|
709.5 h*ng/mL
Standard Deviation 262.84
|
—
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dosePopulation: The PK set included all participants in the safety set who had no major protocol deviations that would have affected the PK analysis and who had sufficient data to calculate PK parameters.
Outcome measures
| Measure |
Part 2: TAK-788 160 mg Fasted
n=10 Participants
TAK-788, 160 mg, capsule, orally, under fasted conditions (Treatment B), once on Day 1 of either Intervention Period 1 or 2.
|
Part 3: TAK-788 160 mg DiC A
TAK-788 160 mg, DiC A (reference), orally, under fasted condition, once on Day 1 of Intervention Period 1.
|
Part 3: TAK-788 160 mg DiC B
TAK-788 160 mg, DiC B (test), orally, under fasted condition, once, on Day 1 of Intervention Period 1.
|
Part 2: TAK-788 120 mg Fed
n=6 Participants
TAK-788 120 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
|
Part 2: TAK-788 120 mg Fasted
n=6 Participants
TAK-788, 120 mg, capsule, orally, once on Day 1 of Intervention Period 1 under fasted conditions (Treatment B).
|
Part 2: TAK-788 160 mg Fed
n=10 Participants
TAK-788, 160 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
|
|---|---|---|---|---|---|---|
|
Part 2, t1/2z: Terminal Disposition Phase Half-life (t1/2z) for TAK-788
|
20.62 hour
Standard Deviation 6.854
|
—
|
—
|
17.17 hour
Standard Deviation 2.629
|
17.60 hour
Standard Deviation 4.067
|
20.72 hour
Standard Deviation 4.827
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dosePopulation: The PK set included all participants in the safety set who had no major protocol deviations that would have affected the PK analysis and who had sufficient data to calculate PK parameters.
Outcome measures
| Measure |
Part 2: TAK-788 160 mg Fasted
TAK-788, 160 mg, capsule, orally, under fasted conditions (Treatment B), once on Day 1 of either Intervention Period 1 or 2.
|
Part 3: TAK-788 160 mg DiC A
TAK-788 160 mg, DiC A (reference), orally, under fasted condition, once on Day 1 of Intervention Period 1.
|
Part 3: TAK-788 160 mg DiC B
TAK-788 160 mg, DiC B (test), orally, under fasted condition, once, on Day 1 of Intervention Period 1.
|
Part 2: TAK-788 120 mg Fed
n=12 Participants
TAK-788 120 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
|
Part 2: TAK-788 120 mg Fasted
n=12 Participants
TAK-788, 120 mg, capsule, orally, once on Day 1 of Intervention Period 1 under fasted conditions (Treatment B).
|
Part 2: TAK-788 160 mg Fed
TAK-788, 160 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
|
|---|---|---|---|---|---|---|
|
Part 3, t1/2z: Terminal Disposition Phase Half-life (t1/2z) for TAK-788
|
—
|
—
|
—
|
16.38 hour
Standard Deviation 2.007
|
16.38 hour
Standard Deviation 2.858
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dosePopulation: The PK set included all participants in the safety set who had no major protocol deviations that would have affected the PK analysis and who had sufficient data to calculate PK parameters.
Outcome measures
| Measure |
Part 2: TAK-788 160 mg Fasted
n=6 Participants
TAK-788, 160 mg, capsule, orally, under fasted conditions (Treatment B), once on Day 1 of either Intervention Period 1 or 2.
|
Part 3: TAK-788 160 mg DiC A
n=6 Participants
TAK-788 160 mg, DiC A (reference), orally, under fasted condition, once on Day 1 of Intervention Period 1.
|
Part 3: TAK-788 160 mg DiC B
TAK-788 160 mg, DiC B (test), orally, under fasted condition, once, on Day 1 of Intervention Period 1.
|
Part 2: TAK-788 120 mg Fed
n=6 Participants
TAK-788 120 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
|
Part 2: TAK-788 120 mg Fasted
n=6 Participants
TAK-788, 120 mg, capsule, orally, once on Day 1 of Intervention Period 1 under fasted conditions (Treatment B).
|
Part 2: TAK-788 160 mg Fed
n=6 Participants
TAK-788, 160 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
|
|---|---|---|---|---|---|---|
|
Part 1, Cmax: Maximum Observed Plasma Concentration for TAK-788 and Its Active Metabolites AP32960 and AP32914
TAK-788
|
25.81 ng/mL
Standard Deviation 9.682
|
52.21 ng/mL
Standard Deviation 27.681
|
—
|
3.22 ng/mL
Standard Deviation 0.938
|
7.85 ng/mL
Standard Deviation 4.206
|
14.66 ng/mL
Standard Deviation 11.649
|
|
Part 1, Cmax: Maximum Observed Plasma Concentration for TAK-788 and Its Active Metabolites AP32960 and AP32914
Metabolite AP32960
|
13.417 ng/mL
Standard Deviation 5.5667
|
25.411 ng/mL
Standard Deviation 10.7473
|
—
|
1.546 ng/mL
Standard Deviation 0.4914
|
3.483 ng/mL
Standard Deviation 0.8827
|
8.298 ng/mL
Standard Deviation 5.5055
|
|
Part 1, Cmax: Maximum Observed Plasma Concentration for TAK-788 and Its Active Metabolites AP32960 and AP32914
Metabolite AP32914
|
2.036 ng/mL
Standard Deviation 0.6433
|
4.051 ng/mL
Standard Deviation 1.8778
|
—
|
NA ng/mL
Standard Deviation NA
Data could not be derived since concentration values were below quantifiable limit less than (\<) 0.1 ng/mL.
|
0.735 ng/mL
Standard Deviation 0.2221
|
1.315 ng/mL
Standard Deviation 1.0492
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dosePopulation: The PK set included all participants in the safety set who had no major protocol deviations that would have affected the PK analysis and who had sufficient data to calculate PK parameters.
Outcome measures
| Measure |
Part 2: TAK-788 160 mg Fasted
n=6 Participants
TAK-788, 160 mg, capsule, orally, under fasted conditions (Treatment B), once on Day 1 of either Intervention Period 1 or 2.
|
Part 3: TAK-788 160 mg DiC A
n=6 Participants
TAK-788 160 mg, DiC A (reference), orally, under fasted condition, once on Day 1 of Intervention Period 1.
|
Part 3: TAK-788 160 mg DiC B
TAK-788 160 mg, DiC B (test), orally, under fasted condition, once, on Day 1 of Intervention Period 1.
|
Part 2: TAK-788 120 mg Fed
n=6 Participants
TAK-788 120 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
|
Part 2: TAK-788 120 mg Fasted
n=6 Participants
TAK-788, 120 mg, capsule, orally, once on Day 1 of Intervention Period 1 under fasted conditions (Treatment B).
|
Part 2: TAK-788 160 mg Fed
n=6 Participants
TAK-788, 160 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
|
|---|---|---|---|---|---|---|
|
Part 1, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-788 and Its Active Metabolites AP32960 and AP32914
TAK-788
|
6.0 hour
Interval 2.0 to 6.0
|
6.0 hour
Interval 4.0 to 6.0
|
—
|
6.0 hour
Interval 2.0 to 8.08
|
5.0 hour
Interval 4.0 to 6.0
|
4.0 hour
Interval 4.0 to 8.0
|
|
Part 1, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-788 and Its Active Metabolites AP32960 and AP32914
Metabolite AP32960
|
6.0 hour
Interval 6.0 to 6.0
|
5.0 hour
Interval 4.0 to 6.0
|
—
|
6.0 hour
Interval 2.0 to 8.08
|
4.0 hour
Interval 4.0 to 6.0
|
4.0 hour
Interval 2.0 to 6.0
|
|
Part 1, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-788 and Its Active Metabolites AP32960 and AP32914
Metabolite AP32914
|
6.0 hour
Interval 6.0 to 6.0
|
6.0 hour
Interval 4.0 to 6.0
|
—
|
NA hour
Data could not be derived since concentration values were below quantifiable limit \< 0.1 ng/mL.
|
6.0 hour
Interval 4.0 to 8.0
|
4.0 hour
Interval 4.0 to 8.0
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dosePopulation: The PK set included all participants in the safety set who had no major protocol deviations that would have affected the PK analysis and who had sufficient data to calculate PK parameters.
Outcome measures
| Measure |
Part 2: TAK-788 160 mg Fasted
n=6 Participants
TAK-788, 160 mg, capsule, orally, under fasted conditions (Treatment B), once on Day 1 of either Intervention Period 1 or 2.
|
Part 3: TAK-788 160 mg DiC A
n=6 Participants
TAK-788 160 mg, DiC A (reference), orally, under fasted condition, once on Day 1 of Intervention Period 1.
|
Part 3: TAK-788 160 mg DiC B
TAK-788 160 mg, DiC B (test), orally, under fasted condition, once, on Day 1 of Intervention Period 1.
|
Part 2: TAK-788 120 mg Fed
n=6 Participants
TAK-788 120 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
|
Part 2: TAK-788 120 mg Fasted
n=6 Participants
TAK-788, 120 mg, capsule, orally, once on Day 1 of Intervention Period 1 under fasted conditions (Treatment B).
|
Part 2: TAK-788 160 mg Fed
n=6 Participants
TAK-788, 160 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
|
|---|---|---|---|---|---|---|
|
Part 1, AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for TAK-788 and Its Active Metabolites, AP32960 and AP32914
Metabolite AP32960
|
284.0 h*ng/mL
Standard Deviation 125.52
|
538.5 h*ng/mL
Standard Deviation 196.10
|
—
|
32.7 h*ng/mL
Standard Deviation 6.41
|
74.9 h*ng/mL
Standard Deviation 21.89
|
159.3 h*ng/mL
Standard Deviation 77.04
|
|
Part 1, AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for TAK-788 and Its Active Metabolites, AP32960 and AP32914
TAK-788
|
448.3 h*ng/mL
Standard Deviation 184.43
|
1007.8 h*ng/mL
Standard Deviation 596.14
|
—
|
59.4 h*ng/mL
Standard Deviation 7.07
|
155.2 h*ng/mL
Standard Deviation 112.06
|
250.4 h*ng/mL
Standard Deviation 197.25
|
|
Part 1, AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for TAK-788 and Its Active Metabolites, AP32960 and AP32914
Metabolite AP32914
|
31.74 h*ng/mL
Standard Deviation 11.370
|
80.40 h*ng/mL
Standard Deviation 47.696
|
—
|
NA h*ng/mL
Standard Deviation NA
Data could not be derived since concentration values were below quantifiable limit less than 0.1 ng/mL.
|
11.53 h*ng/mL
Standard Deviation 6.092
|
14.59 h*ng/mL
Standard Deviation 11.845
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dosePopulation: The PK set included all participants in the safety set who had no major protocol deviations that would have affected the PK analysis and who had sufficient data to calculate PK parameters. The PK analysis population where data at specified time points were available.
Outcome measures
| Measure |
Part 2: TAK-788 160 mg Fasted
n=6 Participants
TAK-788, 160 mg, capsule, orally, under fasted conditions (Treatment B), once on Day 1 of either Intervention Period 1 or 2.
|
Part 3: TAK-788 160 mg DiC A
n=6 Participants
TAK-788 160 mg, DiC A (reference), orally, under fasted condition, once on Day 1 of Intervention Period 1.
|
Part 3: TAK-788 160 mg DiC B
TAK-788 160 mg, DiC B (test), orally, under fasted condition, once, on Day 1 of Intervention Period 1.
|
Part 2: TAK-788 120 mg Fed
n=6 Participants
TAK-788 120 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
|
Part 2: TAK-788 120 mg Fasted
n=6 Participants
TAK-788, 120 mg, capsule, orally, once on Day 1 of Intervention Period 1 under fasted conditions (Treatment B).
|
Part 2: TAK-788 160 mg Fed
n=6 Participants
TAK-788, 160 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
|
|---|---|---|---|---|---|---|
|
Part 1, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-788 and Its Active Metabolites AP32960 and AP32914
TAK-788
|
456.1 h*ng/mL
Standard Deviation 187.20
|
1017.3 h*ng/mL
Standard Deviation 599.11
|
—
|
63.6 h*ng/mL
Standard Deviation 7.11
|
160.4 h*ng/mL
Standard Deviation 115.57
|
256.9 h*ng/mL
Standard Deviation 203.43
|
|
Part 1, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-788 and Its Active Metabolites AP32960 and AP32914
Metabolite AP32960
|
293.4 h*ng/mL
Standard Deviation 124.35
|
548.0 h*ng/mL
Standard Deviation 198.24
|
—
|
37.4 h*ng/mL
Standard Deviation 6.23
|
79.8 h*ng/mL
Standard Deviation 22.41
|
165.9 h*ng/mL
Standard Deviation 81.28
|
|
Part 1, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-788 and Its Active Metabolites AP32960 and AP32914
Metabolite AP32914
|
34.58 h*ng/mL
Standard Deviation 11.482
|
85.16 h*ng/mL
Standard Deviation 48.623
|
—
|
NA h*ng/mL
Standard Deviation NA
Data could not be derived since concentration values were below quantifiable limit less than 0.1 ng/mL.
|
19.27 h*ng/mL
Standard Deviation 3.111
|
20.34 h*ng/mL
Standard Deviation 12.714
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dosePopulation: The PK set included all participants in the safety set who had no major protocol deviations that would have affected the PK analysis and who had sufficient data to calculate PK parameters. The PK analysis population where data at specified time points were available.
Outcome measures
| Measure |
Part 2: TAK-788 160 mg Fasted
n=6 Participants
TAK-788, 160 mg, capsule, orally, under fasted conditions (Treatment B), once on Day 1 of either Intervention Period 1 or 2.
|
Part 3: TAK-788 160 mg DiC A
n=6 Participants
TAK-788 160 mg, DiC A (reference), orally, under fasted condition, once on Day 1 of Intervention Period 1.
|
Part 3: TAK-788 160 mg DiC B
TAK-788 160 mg, DiC B (test), orally, under fasted condition, once, on Day 1 of Intervention Period 1.
|
Part 2: TAK-788 120 mg Fed
n=6 Participants
TAK-788 120 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
|
Part 2: TAK-788 120 mg Fasted
n=6 Participants
TAK-788, 120 mg, capsule, orally, once on Day 1 of Intervention Period 1 under fasted conditions (Treatment B).
|
Part 2: TAK-788 160 mg Fed
n=6 Participants
TAK-788, 160 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
|
|---|---|---|---|---|---|---|
|
Part 1, t1/2z: Terminal Disposition Phase Half-life (t1/2z) for TAK-788 and Its Active Metabolites AP32960 and AP32914
Metabolite AP32960
|
28.93 hour
Standard Deviation 5.903
|
29.18 hour
Standard Deviation 6.368
|
—
|
23.96 hour
Standard Deviation 3.461
|
21.43 hour
Standard Deviation 2.979
|
22.19 hour
Standard Deviation 1.137
|
|
Part 1, t1/2z: Terminal Disposition Phase Half-life (t1/2z) for TAK-788 and Its Active Metabolites AP32960 and AP32914
TAK-788
|
18.30 hour
Standard Deviation 1.286
|
19.85 hour
Standard Deviation 5.464
|
—
|
18.07 hour
Standard Deviation 1.477
|
15.95 hour
Standard Deviation 4.593
|
14.25 hour
Standard Deviation 4.310
|
|
Part 1, t1/2z: Terminal Disposition Phase Half-life (t1/2z) for TAK-788 and Its Active Metabolites AP32960 and AP32914
Metabolite AP32914
|
12.02 hour
Standard Deviation 1.162
|
16.09 hour
Standard Deviation 4.548
|
—
|
NA hour
Standard Deviation NA
Data could not be derived since concentration values were below quantifiable limit less than 0.1 ng/mL.
|
13.75 hour
Standard Deviation 3.323
|
12.22 hour
Standard Deviation 2.084
|
SECONDARY outcome
Timeframe: Baseline up to 30 days after the last dose of study drug (Day 38) (end of Intervention Period 2)Population: The safety set included all participants who received any study treatment.
Outcome measures
| Measure |
Part 2: TAK-788 160 mg Fasted
n=10 Participants
TAK-788, 160 mg, capsule, orally, under fasted conditions (Treatment B), once on Day 1 of either Intervention Period 1 or 2.
|
Part 3: TAK-788 160 mg DiC A
n=12 Participants
TAK-788 160 mg, DiC A (reference), orally, under fasted condition, once on Day 1 of Intervention Period 1.
|
Part 3: TAK-788 160 mg DiC B
n=13 Participants
TAK-788 160 mg, DiC B (test), orally, under fasted condition, once, on Day 1 of Intervention Period 1.
|
Part 2: TAK-788 120 mg Fed
n=6 Participants
TAK-788 120 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
|
Part 2: TAK-788 120 mg Fasted
n=6 Participants
TAK-788, 120 mg, capsule, orally, once on Day 1 of Intervention Period 1 under fasted conditions (Treatment B).
|
Part 2: TAK-788 160 mg Fed
n=10 Participants
TAK-788, 160 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
|
|---|---|---|---|---|---|---|
|
Parts 2 and 3: Number of Participants Reporting One or More TEAEs
|
5 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 30 days after the last dose of study drug (Day 38) (end of Intervention Period 2)Population: The safety set included all participants who received any study treatment.
Outcome measures
| Measure |
Part 2: TAK-788 160 mg Fasted
n=10 Participants
TAK-788, 160 mg, capsule, orally, under fasted conditions (Treatment B), once on Day 1 of either Intervention Period 1 or 2.
|
Part 3: TAK-788 160 mg DiC A
n=12 Participants
TAK-788 160 mg, DiC A (reference), orally, under fasted condition, once on Day 1 of Intervention Period 1.
|
Part 3: TAK-788 160 mg DiC B
n=13 Participants
TAK-788 160 mg, DiC B (test), orally, under fasted condition, once, on Day 1 of Intervention Period 1.
|
Part 2: TAK-788 120 mg Fed
n=6 Participants
TAK-788 120 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
|
Part 2: TAK-788 120 mg Fasted
n=6 Participants
TAK-788, 120 mg, capsule, orally, once on Day 1 of Intervention Period 1 under fasted conditions (Treatment B).
|
Part 2: TAK-788 160 mg Fed
n=10 Participants
TAK-788, 160 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
|
|---|---|---|---|---|---|---|
|
Parts 2 and 3: Number of Participants With One or More SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 30 days after the last dose of study drug (Day 38) (end of Intervention Period 2)Population: The safety set included all participants who received any study treatment.
Outcome measures
| Measure |
Part 2: TAK-788 160 mg Fasted
n=10 Participants
TAK-788, 160 mg, capsule, orally, under fasted conditions (Treatment B), once on Day 1 of either Intervention Period 1 or 2.
|
Part 3: TAK-788 160 mg DiC A
n=12 Participants
TAK-788 160 mg, DiC A (reference), orally, under fasted condition, once on Day 1 of Intervention Period 1.
|
Part 3: TAK-788 160 mg DiC B
n=13 Participants
TAK-788 160 mg, DiC B (test), orally, under fasted condition, once, on Day 1 of Intervention Period 1.
|
Part 2: TAK-788 120 mg Fed
n=6 Participants
TAK-788 120 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
|
Part 2: TAK-788 120 mg Fasted
n=6 Participants
TAK-788, 120 mg, capsule, orally, once on Day 1 of Intervention Period 1 under fasted conditions (Treatment B).
|
Part 2: TAK-788 160 mg Fed
n=10 Participants
TAK-788, 160 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
|
|---|---|---|---|---|---|---|
|
Parts 2 and 3: Number of Participants With Clinically Significant Abnormal Laboratory Values
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 30 days after the last dose of study drug (Day 38) (end of Intervention Period 2)Population: The safety set included all participants who received any study treatment.
Outcome measures
| Measure |
Part 2: TAK-788 160 mg Fasted
n=10 Participants
TAK-788, 160 mg, capsule, orally, under fasted conditions (Treatment B), once on Day 1 of either Intervention Period 1 or 2.
|
Part 3: TAK-788 160 mg DiC A
n=12 Participants
TAK-788 160 mg, DiC A (reference), orally, under fasted condition, once on Day 1 of Intervention Period 1.
|
Part 3: TAK-788 160 mg DiC B
n=13 Participants
TAK-788 160 mg, DiC B (test), orally, under fasted condition, once, on Day 1 of Intervention Period 1.
|
Part 2: TAK-788 120 mg Fed
n=6 Participants
TAK-788 120 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
|
Part 2: TAK-788 120 mg Fasted
n=6 Participants
TAK-788, 120 mg, capsule, orally, once on Day 1 of Intervention Period 1 under fasted conditions (Treatment B).
|
Part 2: TAK-788 160 mg Fed
n=10 Participants
TAK-788, 160 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
|
|---|---|---|---|---|---|---|
|
Parts 2 and 3: Number of Participants With Clinically Significant Abnormal Vital Signs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Part 1: Pooled Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1 Cohort 1: TAK-788 20 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1 Cohort 2: TAK-788 40 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1 Cohort 3: TAK-788 80 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 1 Cohort 4: TAK-788 120 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1 Cohort 5: TAK-788 160 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 2: TAK-788 120 mg Fed
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 2: TAK-788 120 mg Fasted
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 2: TAK-788 160 mg Fed
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Part 2: TAK-788 160 mg Fasted
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 3: TAK-788 DiC A
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 3: TAK-788 DiC B
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 1: Pooled Placebo
n=10 participants at risk
TAK-788 matching placebo capsule, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 1: TAK-788 20 mg
n=6 participants at risk
TAK-788 20 mg, capsule, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 2: TAK-788 40 mg
n=6 participants at risk
TAK-788 40 mg, capsule, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 3: TAK-788 80 mg
n=6 participants at risk
TAK-788 80 mg, capsule, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 4: TAK-788 120 mg
n=6 participants at risk
TAK-788 120 mg, capsule, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 5: TAK-788 160 mg
n=6 participants at risk
TAK-788 160 mg, capsule, orally, once under fasted conditions on Day 1.
|
Part 2: TAK-788 120 mg Fed
n=6 participants at risk
TAK-788 120 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
|
Part 2: TAK-788 120 mg Fasted
n=6 participants at risk
TAK-788, 120 mg, capsule, orally, under fasted conditions (Treatment B), once on Day 1 of either Intervention Period 1 or 2.
|
Part 2: TAK-788 160 mg Fed
n=10 participants at risk
TAK-788, 160 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
|
Part 2: TAK-788 160 mg Fasted
n=10 participants at risk
TAK-788, 160 mg, capsule, orally, under fasted conditions (Treatment B), once on Day 1 of either Intervention Period 1 or 2.
|
Part 3: TAK-788 DiC A
n=13 participants at risk
TAK-788 160 mg, DiC A (reference), orally, under fasted condition, once on Day 1 of either Intervention Period 1 or 2.
|
Part 3: TAK-788 DiC B
n=12 participants at risk
TAK-788 160 mg, DiC B (test), orally, under fasted condition, once on Day 1 of either Intervention Period 1 or 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
10.0%
1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
3/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
30.0%
3/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
40.0%
4/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
10.0%
1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
2/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
8.3%
1/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Injection site cellulitis
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Lipase increased
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
2/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
2/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
30.0%
3/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Dizziness
|
10.0%
1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Eye disorders
Eye pain
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Faeces soft
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
8.3%
1/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Chest discomfort
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Feeling hot
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Injection site phlebitis
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Pain
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Amylase increased
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Haematoma
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
8.3%
1/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Pyrexia
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
8.3%
1/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
8.3%
1/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
8.3%
1/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
8.3%
1/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
- Publication restrictions are in place
Restriction type: OTHER