Trial Outcomes & Findings for A Study Assessing the Safety of Oral ATH-399A in Healthy Adult Participants (NCT NCT06088784)
NCT ID: NCT06088784
Last Updated: 2025-12-19
Results Overview
Participants with abnormal findings on physical and neurological examination (pooled data from the whole study)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
76 participants
Primary outcome timeframe
Part 1a, 1b, 2: Screening, D-1, D3 (Discharge or early termination), Follow-Up: Part 1a: Day 8, Part 1b: Day 16; and Part 2: Day 19
Results posted on
2025-12-19
Participant Flow
Part 1a: 40 participants randomized Part 1b: 12 participants randomized Part 2: 24 participants randomized
Participant milestones
| Measure |
Part 1a (SAD): ATH-399A 5 mg
Each participant received a single oral dose of 5 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 10 mg
Each participant received a single oral dose of 10 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 20 mg
Each participant received a single oral dose of 20 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 40 mg
Each participant received a single oral dose of 40 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 80 mg
Each participant received a single oral dose of 80 mg of ATH-399A.
|
Part 1a (SAD): Placebo
Each participant received a single dose of matching placebo.
|
Part 1b (Food Effect): ATH-399A 40 mg, Sequence AB
Participants in Part 1b were randomized to one of the 2 arms to receive study drugs in the cross-over sequence AB or BA.
* Treatment A: ATH-399A 40 mg was administered following a high-fat, high-calorie meal.
* Treatment B: Participants were restricted from eating 10 hours prior to and 4 hours following ATH-399A 40 mg administration.
|
Part 1b (Food Effect): ATH-399A 40 mg, Sequence BA
Participants in Part 1b were randomized to one of the 2 arms to receive study drugs in the cross-over sequence AB or BA.
* Treatment A: ATH-399A 40 mg was administered following a high-fat, high-calorie meal.
* Treatment B: Participants were restricted from eating 10 hours prior to and 4 hours following ATH-399A 40 mg administration.
|
Part 2 (MAD): ATH-399A 20 mg
Each participant received ATH-399A 20 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
Part 2 (MAD): ATH-399A 40 mg
Each participant received ATH-399A 40 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
Part 2 (MAD): ATH-399A 40 mg, Older
Each participant aged \>55-80 years received ATH-399A 40 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
Part 2 (MAD): Placebo
Each participant received a single dose of matching placebo.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
6
|
10
|
6
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
6
|
10
|
2
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Part 1a (SAD): ATH-399A 5 mg
Each participant received a single oral dose of 5 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 10 mg
Each participant received a single oral dose of 10 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 20 mg
Each participant received a single oral dose of 20 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 40 mg
Each participant received a single oral dose of 40 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 80 mg
Each participant received a single oral dose of 80 mg of ATH-399A.
|
Part 1a (SAD): Placebo
Each participant received a single dose of matching placebo.
|
Part 1b (Food Effect): ATH-399A 40 mg, Sequence AB
Participants in Part 1b were randomized to one of the 2 arms to receive study drugs in the cross-over sequence AB or BA.
* Treatment A: ATH-399A 40 mg was administered following a high-fat, high-calorie meal.
* Treatment B: Participants were restricted from eating 10 hours prior to and 4 hours following ATH-399A 40 mg administration.
|
Part 1b (Food Effect): ATH-399A 40 mg, Sequence BA
Participants in Part 1b were randomized to one of the 2 arms to receive study drugs in the cross-over sequence AB or BA.
* Treatment A: ATH-399A 40 mg was administered following a high-fat, high-calorie meal.
* Treatment B: Participants were restricted from eating 10 hours prior to and 4 hours following ATH-399A 40 mg administration.
|
Part 2 (MAD): ATH-399A 20 mg
Each participant received ATH-399A 20 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
Part 2 (MAD): ATH-399A 40 mg
Each participant received ATH-399A 40 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
Part 2 (MAD): ATH-399A 40 mg, Older
Each participant aged \>55-80 years received ATH-399A 40 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
Part 2 (MAD): Placebo
Each participant received a single dose of matching placebo.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Exclusion criterion: QTcF >450 msec
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study Assessing the Safety of Oral ATH-399A in Healthy Adult Participants
Baseline characteristics by cohort
| Measure |
Part 1a (SAD): ATH-399A 5 mg
n=6 Participants
Each participant received a single oral dose of 5 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 10 mg
n=6 Participants
Each participant received a single oral dose of 10 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 20 mg
n=6 Participants
Each participant received a single oral dose of 20 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 40 mg
n=6 Participants
Each participant received a single oral dose of 40 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 80 mg
n=6 Participants
Each participant received a single oral dose of 80 mg of ATH-399A.
|
Part 1a (SAD): Placebo
n=10 Participants
Each participant received a single dose of matching placebo.
|
Part 1b (Food Effect): ATH-399A 40 mg, Sequence AB
n=6 Participants
Participants in Part 1b were randomized to one of the 2 arms to receive study drugs in the cross-over sequence AB or BA.
* Treatment A: ATH-399A 40 mg was administered following a high-fat, high-calorie meal.
* Treatment B: Participants were restricted from eating 10 hours prior to and 4 hours following ATH-399A 40 mg administration.
|
Part 1b (Food Effect): ATH-399A 40 mg, Sequence BA
n=6 Participants
Participants in Part 1b were randomized to one of the 2 arms to receive study drugs in the cross-over sequence AB or BA.
* Treatment A: ATH-399A 40 mg was administered following a high-fat, high-calorie meal.
* Treatment B: Participants were restricted from eating 10 hours prior to and 4 hours following ATH-399A 40 mg administration.
|
Part 2 (MAD): ATH-399A 20 mg
n=6 Participants
Each participant received ATH-399A 20 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
Part 2 (MAD): ATH-399A 40 mg
n=6 Participants
Each participant received ATH-399A 40 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
Part 2 (MAD): ATH-399A 40 mg, Older
n=6 Participants
Each participant aged \>55-80 years received ATH-399A 40 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
Part 2 (MAD): Placebo
n=6 Participants
Each participant received a single dose of matching placebo.
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
36.7 years
STANDARD_DEVIATION 8.07 • n=9 Participants
|
35.5 years
STANDARD_DEVIATION 10.80 • n=6 Participants
|
50.0 years
STANDARD_DEVIATION 5.29 • n=9 Participants
|
39.0 years
STANDARD_DEVIATION 8.88 • n=17 Participants
|
42.8 years
STANDARD_DEVIATION 5.46 • n=16 Participants
|
39.2 years
STANDARD_DEVIATION 8.88 • n=82 Participants
|
37.0 years
STANDARD_DEVIATION 13.34 • n=13 Participants
|
41.5 years
STANDARD_DEVIATION 10.05 • n=335 Participants
|
35.7 years
STANDARD_DEVIATION 11.72 • n=451 Participants
|
47.0 years
STANDARD_DEVIATION 6.96 • n=6 Participants
|
64.8 years
STANDARD_DEVIATION 5.31 • n=6 Participants
|
50.2 years
STANDARD_DEVIATION 12.64 • n=6 Participants
|
43.07 years
STANDARD_DEVIATION 11.8292 • n=6 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=9 Participants
|
2 Participants
n=6 Participants
|
4 Participants
n=9 Participants
|
0 Participants
n=17 Participants
|
4 Participants
n=16 Participants
|
6 Participants
n=82 Participants
|
2 Participants
n=13 Participants
|
3 Participants
n=335 Participants
|
2 Participants
n=451 Participants
|
1 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
32 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=9 Participants
|
4 Participants
n=6 Participants
|
2 Participants
n=9 Participants
|
6 Participants
n=17 Participants
|
2 Participants
n=16 Participants
|
4 Participants
n=82 Participants
|
4 Participants
n=13 Participants
|
3 Participants
n=335 Participants
|
4 Participants
n=451 Participants
|
5 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
44 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=9 Participants
|
2 Participants
n=17 Participants
|
2 Participants
n=16 Participants
|
0 Participants
n=82 Participants
|
3 Participants
n=13 Participants
|
2 Participants
n=335 Participants
|
0 Participants
n=451 Participants
|
3 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
19 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=9 Participants
|
5 Participants
n=6 Participants
|
4 Participants
n=9 Participants
|
4 Participants
n=17 Participants
|
4 Participants
n=16 Participants
|
10 Participants
n=82 Participants
|
3 Participants
n=13 Participants
|
4 Participants
n=335 Participants
|
6 Participants
n=451 Participants
|
3 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
57 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=335 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=335 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=335 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=335 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
3 Participants
n=17 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=335 Participants
|
1 Participants
n=451 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
7 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=9 Participants
|
5 Participants
n=6 Participants
|
6 Participants
n=9 Participants
|
3 Participants
n=17 Participants
|
6 Participants
n=16 Participants
|
10 Participants
n=82 Participants
|
6 Participants
n=13 Participants
|
6 Participants
n=335 Participants
|
5 Participants
n=451 Participants
|
5 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
68 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=335 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=335 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Height
|
168.67 cm
STANDARD_DEVIATION 8.134 • n=9 Participants
|
171.08 cm
STANDARD_DEVIATION 6.931 • n=6 Participants
|
163.73 cm
STANDARD_DEVIATION 8.188 • n=9 Participants
|
176.57 cm
STANDARD_DEVIATION 9.528 • n=17 Participants
|
168.33 cm
STANDARD_DEVIATION 6.439 • n=16 Participants
|
166.70 cm
STANDARD_DEVIATION 12.541 • n=82 Participants
|
170.92 cm
STANDARD_DEVIATION 8.357 • n=13 Participants
|
167.68 cm
STANDARD_DEVIATION 7.427 • n=335 Participants
|
172.70 cm
STANDARD_DEVIATION 10.050 • n=451 Participants
|
171.83 cm
STANDARD_DEVIATION 7.757 • n=6 Participants
|
170.68 cm
STANDARD_DEVIATION 7.105 • n=6 Participants
|
174.25 cm
STANDARD_DEVIATION 8.802 • n=6 Participants
|
170.08 cm
STANDARD_DEVIATION 8.8719 • n=6 Participants
|
|
Weight
|
70.43 kg
STANDARD_DEVIATION 11.316 • n=9 Participants
|
71.83 kg
STANDARD_DEVIATION 7.689 • n=6 Participants
|
64.52 kg
STANDARD_DEVIATION 11.874 • n=9 Participants
|
79.93 kg
STANDARD_DEVIATION 15.591 • n=17 Participants
|
74.25 kg
STANDARD_DEVIATION 12.798 • n=16 Participants
|
67.15 kg
STANDARD_DEVIATION 9.957 • n=82 Participants
|
76.12 kg
STANDARD_DEVIATION 14.787 • n=13 Participants
|
69.20 kg
STANDARD_DEVIATION 11.516 • n=335 Participants
|
72.87 kg
STANDARD_DEVIATION 15.164 • n=451 Participants
|
79.92 kg
STANDARD_DEVIATION 10.198 • n=6 Participants
|
69.92 kg
STANDARD_DEVIATION 11.940 • n=6 Participants
|
76.10 kg
STANDARD_DEVIATION 12.381 • n=6 Participants
|
72.39 kg
STANDARD_DEVIATION 12.1717 • n=6 Participants
|
|
Body Mass Index (BMI)
|
24.72 kg/m2
STANDARD_DEVIATION 3.277 • n=9 Participants
|
24.50 kg/m2
STANDARD_DEVIATION 1.971 • n=6 Participants
|
23.97 kg/m2
STANDARD_DEVIATION 3.236 • n=9 Participants
|
25.48 kg/m2
STANDARD_DEVIATION 3.388 • n=17 Participants
|
26.03 kg/m2
STANDARD_DEVIATION 3.027 • n=16 Participants
|
24.16 kg/m2
STANDARD_DEVIATION 2.476 • n=82 Participants
|
25.90 kg/m2
STANDARD_DEVIATION 3.551 • n=13 Participants
|
24.60 kg/m2
STANDARD_DEVIATION 3.529 • n=335 Participants
|
24.22 kg/m2
STANDARD_DEVIATION 3.573 • n=451 Participants
|
26.93 kg/m2
STANDARD_DEVIATION 1.507 • n=6 Participants
|
23.87 kg/m2
STANDARD_DEVIATION 2.889 • n=6 Participants
|
24.93 kg/m2
STANDARD_DEVIATION 2.479 • n=6 Participants
|
24.90 kg/m2
STANDARD_DEVIATION 2.8730 • n=6 Participants
|
PRIMARY outcome
Timeframe: Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
Outcome measures
| Measure |
Part 1b (Food Effect): ATH-399A 40 mg, Fed
n=12 Participants
ATH-399A 40 mg was administered following a high-fat, high-calorie meal.
|
Part 1b (Food Effect): ATH-399A 40 mg, Fasted
n=8 Participants
Participants were restricted from eating 10 hours prior to and 4 hours following ATH-399A 40 mg administration.
|
Part 1b (Food Effect): ATH-399A 40 mg, Fed
n=10 Participants
ATH-399A 40 mg was administered following a high-fat, high-calorie meal.
|
Part 1a (SAD): ATH-399A 80 mg
n=6 Participants
Each participant received a single oral dose of 80 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 10 mg
n=6 Participants
Each participant received a single oral dose of 10 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 20 mg
n=6 Participants
Each participant received a single oral dose of 20 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 40 mg
n=6 Participants
Each participant received a single oral dose of 40 mg of ATH-399A.
|
Part 2 (MAD): Placebo
n=6 Participants
Each participant received a single dose of matching placebo.
|
Part 1a (SAD): ATH-399A 5 mg
n=6 Participants
Each participant received a single oral dose of 5 mg of ATH-399A.
|
Part 2 (MAD): ATH-399A 20 mg
n=6 Participants
Each participant received ATH-399A 20 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
Part 2 (MAD): ATH-399A 40 mg
n=6 Participants
Each participant received ATH-399A 40 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
Part 2 (MAD): ATH-399A 40 mg, Older
n=6 Participants
Each participant aged \>55-80 years received ATH-399A 40 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of TEAEs
|
3 Treatment Emergent Adverse Event
|
1 Treatment Emergent Adverse Event
|
3 Treatment Emergent Adverse Event
|
2 Treatment Emergent Adverse Event
|
2 Treatment Emergent Adverse Event
|
1 Treatment Emergent Adverse Event
|
3 Treatment Emergent Adverse Event
|
6 Treatment Emergent Adverse Event
|
4 Treatment Emergent Adverse Event
|
4 Treatment Emergent Adverse Event
|
2 Treatment Emergent Adverse Event
|
10 Treatment Emergent Adverse Event
|
PRIMARY outcome
Timeframe: Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19Participants with at least one AE started or after the time of first study drug administration.
Outcome measures
| Measure |
Part 1b (Food Effect): ATH-399A 40 mg, Fed
n=12 Participants
ATH-399A 40 mg was administered following a high-fat, high-calorie meal.
|
Part 1b (Food Effect): ATH-399A 40 mg, Fasted
n=8 Participants
Participants were restricted from eating 10 hours prior to and 4 hours following ATH-399A 40 mg administration.
|
Part 1b (Food Effect): ATH-399A 40 mg, Fed
n=10 Participants
ATH-399A 40 mg was administered following a high-fat, high-calorie meal.
|
Part 1a (SAD): ATH-399A 80 mg
n=6 Participants
Each participant received a single oral dose of 80 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 10 mg
n=6 Participants
Each participant received a single oral dose of 10 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 20 mg
n=6 Participants
Each participant received a single oral dose of 20 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 40 mg
n=6 Participants
Each participant received a single oral dose of 40 mg of ATH-399A.
|
Part 2 (MAD): Placebo
n=6 Participants
Each participant received a single dose of matching placebo.
|
Part 1a (SAD): ATH-399A 5 mg
n=6 Participants
Each participant received a single oral dose of 5 mg of ATH-399A.
|
Part 2 (MAD): ATH-399A 20 mg
n=6 Participants
Each participant received ATH-399A 20 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
Part 2 (MAD): ATH-399A 40 mg
n=6 Participants
Each participant received ATH-399A 40 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
Part 2 (MAD): ATH-399A 40 mg, Older
n=6 Participants
Each participant aged \>55-80 years received ATH-399A 40 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Participants With at Least 1 TEAE
|
3 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the criteria listed: Resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or other situations.
Outcome measures
| Measure |
Part 1b (Food Effect): ATH-399A 40 mg, Fed
n=12 Participants
ATH-399A 40 mg was administered following a high-fat, high-calorie meal.
|
Part 1b (Food Effect): ATH-399A 40 mg, Fasted
n=8 Participants
Participants were restricted from eating 10 hours prior to and 4 hours following ATH-399A 40 mg administration.
|
Part 1b (Food Effect): ATH-399A 40 mg, Fed
n=10 Participants
ATH-399A 40 mg was administered following a high-fat, high-calorie meal.
|
Part 1a (SAD): ATH-399A 80 mg
n=6 Participants
Each participant received a single oral dose of 80 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 10 mg
n=6 Participants
Each participant received a single oral dose of 10 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 20 mg
n=6 Participants
Each participant received a single oral dose of 20 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 40 mg
n=6 Participants
Each participant received a single oral dose of 40 mg of ATH-399A.
|
Part 2 (MAD): Placebo
n=6 Participants
Each participant received a single dose of matching placebo.
|
Part 1a (SAD): ATH-399A 5 mg
n=6 Participants
Each participant received a single oral dose of 5 mg of ATH-399A.
|
Part 2 (MAD): ATH-399A 20 mg
n=6 Participants
Each participant received ATH-399A 20 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
Part 2 (MAD): ATH-399A 40 mg
n=6 Participants
Each participant received ATH-399A 40 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
Part 2 (MAD): ATH-399A 40 mg, Older
n=6 Participants
Each participant aged \>55-80 years received ATH-399A 40 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Serious TEAEs
|
0 Serious Treatment Emergent Adverse Event
|
0 Serious Treatment Emergent Adverse Event
|
0 Serious Treatment Emergent Adverse Event
|
0 Serious Treatment Emergent Adverse Event
|
0 Serious Treatment Emergent Adverse Event
|
0 Serious Treatment Emergent Adverse Event
|
0 Serious Treatment Emergent Adverse Event
|
0 Serious Treatment Emergent Adverse Event
|
0 Serious Treatment Emergent Adverse Event
|
0 Serious Treatment Emergent Adverse Event
|
0 Serious Treatment Emergent Adverse Event
|
0 Serious Treatment Emergent Adverse Event
|
PRIMARY outcome
Timeframe: Part 1a, 1b: Screening, Day -1, Follow-up (1a - Day 16; 1b - Day 19); Part 2: Screening, Day -1, Day 13 (Discharge or early termination)Population: Participants in each part were combined for reporting results given there were 0 reports across the study.
Number of participant whose answers indicate suicidal ideation and/or behavior at follow-up.
Outcome measures
| Measure |
Part 1b (Food Effect): ATH-399A 40 mg, Fed
n=6 Participants
ATH-399A 40 mg was administered following a high-fat, high-calorie meal.
|
Part 1b (Food Effect): ATH-399A 40 mg, Fasted
n=10 Participants
Participants were restricted from eating 10 hours prior to and 4 hours following ATH-399A 40 mg administration.
|
Part 1b (Food Effect): ATH-399A 40 mg, Fed
n=6 Participants
ATH-399A 40 mg was administered following a high-fat, high-calorie meal.
|
Part 1a (SAD): ATH-399A 80 mg
n=6 Participants
Each participant received a single oral dose of 80 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 10 mg
n=12 Participants
Each participant received a single oral dose of 10 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 20 mg
n=6 Participants
Each participant received a single oral dose of 20 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 40 mg
n=6 Participants
Each participant received a single oral dose of 40 mg of ATH-399A.
|
Part 2 (MAD): Placebo
n=6 Participants
Each participant received a single dose of matching placebo.
|
Part 1a (SAD): ATH-399A 5 mg
n=6 Participants
Each participant received a single oral dose of 5 mg of ATH-399A.
|
Part 2 (MAD): ATH-399A 20 mg
n=8 Participants
Each participant received ATH-399A 20 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
Part 2 (MAD): ATH-399A 40 mg
n=6 Participants
Each participant received ATH-399A 40 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
Part 2 (MAD): ATH-399A 40 mg, Older
n=6 Participants
Each participant aged \>55-80 years received ATH-399A 40 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Suicidal Ideation and/or Behavior Detected in Columbia Suicidality Severity Rating Scale (C-SSRS)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From baseline to follow up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19Participants with abnormal QTcF on ECG (pooled data from the whole study duration)
Outcome measures
| Measure |
Part 1b (Food Effect): ATH-399A 40 mg, Fed
n=12 Participants
ATH-399A 40 mg was administered following a high-fat, high-calorie meal.
|
Part 1b (Food Effect): ATH-399A 40 mg, Fasted
n=8 Participants
Participants were restricted from eating 10 hours prior to and 4 hours following ATH-399A 40 mg administration.
|
Part 1b (Food Effect): ATH-399A 40 mg, Fed
n=10 Participants
ATH-399A 40 mg was administered following a high-fat, high-calorie meal.
|
Part 1a (SAD): ATH-399A 80 mg
n=6 Participants
Each participant received a single oral dose of 80 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 10 mg
n=6 Participants
Each participant received a single oral dose of 10 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 20 mg
n=6 Participants
Each participant received a single oral dose of 20 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 40 mg
n=6 Participants
Each participant received a single oral dose of 40 mg of ATH-399A.
|
Part 2 (MAD): Placebo
n=6 Participants
Each participant received a single dose of matching placebo.
|
Part 1a (SAD): ATH-399A 5 mg
n=6 Participants
Each participant received a single oral dose of 5 mg of ATH-399A.
|
Part 2 (MAD): ATH-399A 20 mg
n=6 Participants
Each participant received ATH-399A 20 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
Part 2 (MAD): ATH-399A 40 mg
n=6 Participants
Each participant received ATH-399A 40 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
Part 2 (MAD): ATH-399A 40 mg, Older
n=6 Participants
Each participant aged \>55-80 years received ATH-399A 40 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
QTcF Analysis
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Day 1: predose and 1 hour post dosingDiastolic blood pressure baseline value measured at basline Day 1 pre dose and Day 1 1 hour post dosing
Outcome measures
| Measure |
Part 1b (Food Effect): ATH-399A 40 mg, Fed
n=12 Participants
ATH-399A 40 mg was administered following a high-fat, high-calorie meal.
|
Part 1b (Food Effect): ATH-399A 40 mg, Fasted
n=8 Participants
Participants were restricted from eating 10 hours prior to and 4 hours following ATH-399A 40 mg administration.
|
Part 1b (Food Effect): ATH-399A 40 mg, Fed
n=10 Participants
ATH-399A 40 mg was administered following a high-fat, high-calorie meal.
|
Part 1a (SAD): ATH-399A 80 mg
n=6 Participants
Each participant received a single oral dose of 80 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 10 mg
n=6 Participants
Each participant received a single oral dose of 10 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 20 mg
n=6 Participants
Each participant received a single oral dose of 20 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 40 mg
n=6 Participants
Each participant received a single oral dose of 40 mg of ATH-399A.
|
Part 2 (MAD): Placebo
n=6 Participants
Each participant received a single dose of matching placebo.
|
Part 1a (SAD): ATH-399A 5 mg
n=6 Participants
Each participant received a single oral dose of 5 mg of ATH-399A.
|
Part 2 (MAD): ATH-399A 20 mg
n=6 Participants
Each participant received ATH-399A 20 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
Part 2 (MAD): ATH-399A 40 mg
n=6 Participants
Each participant received ATH-399A 40 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
Part 2 (MAD): ATH-399A 40 mg, Older
n=6 Participants
Each participant aged \>55-80 years received ATH-399A 40 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Changes in Diastolic Blood Pressure
Baseline
|
69.8 mmHg
Standard Deviation 6.12
|
69.0 mmHg
Standard Deviation 4.81
|
71.0 mmHg
Standard Deviation 6.46
|
72.5 mmHg
Standard Deviation 7.87
|
70.8 mmHg
Standard Deviation 4.07
|
75.8 mmHg
Standard Deviation 7.39
|
70.7 mmHg
Standard Deviation 4.32
|
71.5 mmHg
Standard Deviation 7.77
|
68.8 mmHg
Standard Deviation 7.73
|
72.8 mmHg
Standard Deviation 3.19
|
72.0 mmHg
Standard Deviation 4.00
|
72.3 mmHg
Standard Deviation 1.97
|
|
Changes in Diastolic Blood Pressure
1 hour post dosing
|
66.1 mmHg
Standard Deviation 6.10
|
70.9 mmHg
Standard Deviation 6.13
|
70.7 mmHg
Standard Deviation 5.89
|
70.5 mmHg
Standard Deviation 7.18
|
69.2 mmHg
Standard Deviation 5.27
|
74.3 mmHg
Standard Deviation 6.74
|
71.8 mmHg
Standard Deviation 6.91
|
73.0 mmHg
Standard Deviation 9.57
|
67.5 mmHg
Standard Deviation 6.35
|
71.8 mmHg
Standard Deviation 5.12
|
70.8 mmHg
Standard Deviation 3.19
|
75.2 mmHg
Standard Deviation 3.19
|
PRIMARY outcome
Timeframe: Day 1 predose and 1 hour postdosingSystolic blood pressure baseline value measured at basline Day 1 pre dose and Day 1 1 hour post dosing
Outcome measures
| Measure |
Part 1b (Food Effect): ATH-399A 40 mg, Fed
n=12 Participants
ATH-399A 40 mg was administered following a high-fat, high-calorie meal.
|
Part 1b (Food Effect): ATH-399A 40 mg, Fasted
n=8 Participants
Participants were restricted from eating 10 hours prior to and 4 hours following ATH-399A 40 mg administration.
|
Part 1b (Food Effect): ATH-399A 40 mg, Fed
n=10 Participants
ATH-399A 40 mg was administered following a high-fat, high-calorie meal.
|
Part 1a (SAD): ATH-399A 80 mg
n=6 Participants
Each participant received a single oral dose of 80 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 10 mg
n=6 Participants
Each participant received a single oral dose of 10 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 20 mg
n=6 Participants
Each participant received a single oral dose of 20 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 40 mg
n=6 Participants
Each participant received a single oral dose of 40 mg of ATH-399A.
|
Part 2 (MAD): Placebo
n=6 Participants
Each participant received a single dose of matching placebo.
|
Part 1a (SAD): ATH-399A 5 mg
n=6 Participants
Each participant received a single oral dose of 5 mg of ATH-399A.
|
Part 2 (MAD): ATH-399A 20 mg
n=6 Participants
Each participant received ATH-399A 20 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
Part 2 (MAD): ATH-399A 40 mg
n=6 Participants
Each participant received ATH-399A 40 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
Part 2 (MAD): ATH-399A 40 mg, Older
n=6 Participants
Each participant aged \>55-80 years received ATH-399A 40 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Changes in Systolic Blood Pressure
1 hour post dosing
|
119.9 mmHg
Standard Deviation 13.99
|
116.5 mmHg
Standard Deviation 9.34
|
109.5 mmHg
Standard Deviation 9.00
|
108.3 mmHg
Standard Deviation 11.04
|
110.8 mmHg
Standard Deviation 7.36
|
117.0 mmHg
Standard Deviation 12.55
|
113.8 mmHg
Standard Deviation 10.23
|
113.5 mmHg
Standard Deviation 9.38
|
105.8 mmHg
Standard Deviation 7.65
|
114.7 mmHg
Standard Deviation 9.50
|
113.8 mmHg
Standard Deviation 5.12
|
123.7 mmHg
Standard Deviation 11.43
|
|
Changes in Systolic Blood Pressure
baseline
|
111.4 mmHg
Standard Deviation 8.05
|
110.1 mmHg
Standard Deviation 7.83
|
111.6 mmHg
Standard Deviation 9.13
|
111.8 mmHg
Standard Deviation 9.64
|
112.0 mmHg
Standard Deviation 4.20
|
119.7 mmHg
Standard Deviation 12.37
|
111.3 mmHg
Standard Deviation 5.24
|
112.7 mmHg
Standard Deviation 11.47
|
107.0 mmHg
Standard Deviation 7.21
|
114.3 mmHg
Standard Deviation 5.39
|
114.5 mmHg
Standard Deviation 9.97
|
116.3 mmHg
Standard Deviation 8.89
|
PRIMARY outcome
Timeframe: Day 1, 1 hour post-doseHeart rate value measured at Day 1, 1 Hour Post-Dose
Outcome measures
| Measure |
Part 1b (Food Effect): ATH-399A 40 mg, Fed
n=12 Participants
ATH-399A 40 mg was administered following a high-fat, high-calorie meal.
|
Part 1b (Food Effect): ATH-399A 40 mg, Fasted
n=8 Participants
Participants were restricted from eating 10 hours prior to and 4 hours following ATH-399A 40 mg administration.
|
Part 1b (Food Effect): ATH-399A 40 mg, Fed
n=10 Participants
ATH-399A 40 mg was administered following a high-fat, high-calorie meal.
|
Part 1a (SAD): ATH-399A 80 mg
n=6 Participants
Each participant received a single oral dose of 80 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 10 mg
n=6 Participants
Each participant received a single oral dose of 10 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 20 mg
n=6 Participants
Each participant received a single oral dose of 20 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 40 mg
n=6 Participants
Each participant received a single oral dose of 40 mg of ATH-399A.
|
Part 2 (MAD): Placebo
n=6 Participants
Each participant received a single dose of matching placebo.
|
Part 1a (SAD): ATH-399A 5 mg
n=6 Participants
Each participant received a single oral dose of 5 mg of ATH-399A.
|
Part 2 (MAD): ATH-399A 20 mg
n=6 Participants
Each participant received ATH-399A 20 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
Part 2 (MAD): ATH-399A 40 mg
n=6 Participants
Each participant received ATH-399A 40 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
Part 2 (MAD): ATH-399A 40 mg, Older
n=6 Participants
Each participant aged \>55-80 years received ATH-399A 40 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Heart Rate Value
|
65.3 beats/min
Standard Deviation 8.86
|
60.6 beats/min
Standard Deviation 5.71
|
64.7 beats/min
Standard Deviation 7.29
|
59.8 beats/min
Standard Deviation 6.05
|
58.3 beats/min
Standard Deviation 6.09
|
55.3 beats/min
Standard Deviation 5.16
|
63.0 beats/min
Standard Deviation 10.81
|
61.0 beats/min
Standard Deviation 7.46
|
59.7 beats/min
Standard Deviation 10.27
|
62.3 beats/min
Standard Deviation 6.22
|
58.7 beats/min
Standard Deviation 8.29
|
63.0 beats/min
Standard Deviation 9.21
|
PRIMARY outcome
Timeframe: Day 1, 1 Hour Post-DoseTemperature value measured at Day 1, 1 Hour Post-Dose
Outcome measures
| Measure |
Part 1b (Food Effect): ATH-399A 40 mg, Fed
n=12 Participants
ATH-399A 40 mg was administered following a high-fat, high-calorie meal.
|
Part 1b (Food Effect): ATH-399A 40 mg, Fasted
n=8 Participants
Participants were restricted from eating 10 hours prior to and 4 hours following ATH-399A 40 mg administration.
|
Part 1b (Food Effect): ATH-399A 40 mg, Fed
n=10 Participants
ATH-399A 40 mg was administered following a high-fat, high-calorie meal.
|
Part 1a (SAD): ATH-399A 80 mg
n=6 Participants
Each participant received a single oral dose of 80 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 10 mg
n=6 Participants
Each participant received a single oral dose of 10 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 20 mg
n=6 Participants
Each participant received a single oral dose of 20 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 40 mg
n=6 Participants
Each participant received a single oral dose of 40 mg of ATH-399A.
|
Part 2 (MAD): Placebo
n=6 Participants
Each participant received a single dose of matching placebo.
|
Part 1a (SAD): ATH-399A 5 mg
n=6 Participants
Each participant received a single oral dose of 5 mg of ATH-399A.
|
Part 2 (MAD): ATH-399A 20 mg
n=6 Participants
Each participant received ATH-399A 20 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
Part 2 (MAD): ATH-399A 40 mg
n=6 Participants
Each participant received ATH-399A 40 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
Part 2 (MAD): ATH-399A 40 mg, Older
n=6 Participants
Each participant aged \>55-80 years received ATH-399A 40 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Temperature Value
|
36.80 °C
Standard Deviation 0.160
|
36.73 °C
Standard Deviation 0.116
|
36.78 °C
Standard Deviation 0.210
|
36.73 °C
Standard Deviation 0.216
|
36.67 °C
Standard Deviation 0.121
|
36.72 °C
Standard Deviation 0.232
|
36.78 °C
Standard Deviation 0.147
|
36.70 °C
Standard Deviation 0.167
|
36.63 °C
Standard Deviation 0.103
|
36.93 °C
Standard Deviation 0.151
|
36.58 °C
Standard Deviation 0.117
|
36.63 °C
Standard Deviation 0.207
|
PRIMARY outcome
Timeframe: Day 1, 1 Hour Post-DoseRespiratory rate value measured at Day 1, 1 Hour Post-Dose
Outcome measures
| Measure |
Part 1b (Food Effect): ATH-399A 40 mg, Fed
n=12 Participants
ATH-399A 40 mg was administered following a high-fat, high-calorie meal.
|
Part 1b (Food Effect): ATH-399A 40 mg, Fasted
n=8 Participants
Participants were restricted from eating 10 hours prior to and 4 hours following ATH-399A 40 mg administration.
|
Part 1b (Food Effect): ATH-399A 40 mg, Fed
n=10 Participants
ATH-399A 40 mg was administered following a high-fat, high-calorie meal.
|
Part 1a (SAD): ATH-399A 80 mg
n=6 Participants
Each participant received a single oral dose of 80 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 10 mg
n=6 Participants
Each participant received a single oral dose of 10 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 20 mg
n=6 Participants
Each participant received a single oral dose of 20 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 40 mg
n=6 Participants
Each participant received a single oral dose of 40 mg of ATH-399A.
|
Part 2 (MAD): Placebo
n=6 Participants
Each participant received a single dose of matching placebo.
|
Part 1a (SAD): ATH-399A 5 mg
n=6 Participants
Each participant received a single oral dose of 5 mg of ATH-399A.
|
Part 2 (MAD): ATH-399A 20 mg
n=6 Participants
Each participant received ATH-399A 20 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
Part 2 (MAD): ATH-399A 40 mg
n=6 Participants
Each participant received ATH-399A 40 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
Part 2 (MAD): ATH-399A 40 mg, Older
n=6 Participants
Each participant aged \>55-80 years received ATH-399A 40 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Respiratory Rate Value
|
15.5 breaths/min
Standard Deviation 3.09
|
14.3 breaths/min
Standard Deviation 1.98
|
13.0 breaths/min
Standard Deviation 3.30
|
14.3 breaths/min
Standard Deviation 2.34
|
16.0 breaths/min
Standard Deviation 3.58
|
13.7 breaths/min
Standard Deviation 1.51
|
13.0 breaths/min
Standard Deviation 3.74
|
13.3 breaths/min
Standard Deviation 2.07
|
14.7 breaths/min
Standard Deviation 2.73
|
14.7 breaths/min
Standard Deviation 1.03
|
15.0 breaths/min
Standard Deviation 1.10
|
13.0 breaths/min
Standard Deviation 3.52
|
PRIMARY outcome
Timeframe: Part 1a, 1b, 2: Screening, D-1, D3 (Discharge or early termination), Follow-Up: Part 1a: Day 8, Part 1b: Day 16; and Part 2: Day 19Participants with abnormal findings on physical and neurological examination (pooled data from the whole study)
Outcome measures
| Measure |
Part 1b (Food Effect): ATH-399A 40 mg, Fed
n=12 Participants
ATH-399A 40 mg was administered following a high-fat, high-calorie meal.
|
Part 1b (Food Effect): ATH-399A 40 mg, Fasted
n=8 Participants
Participants were restricted from eating 10 hours prior to and 4 hours following ATH-399A 40 mg administration.
|
Part 1b (Food Effect): ATH-399A 40 mg, Fed
n=10 Participants
ATH-399A 40 mg was administered following a high-fat, high-calorie meal.
|
Part 1a (SAD): ATH-399A 80 mg
n=6 Participants
Each participant received a single oral dose of 80 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 10 mg
n=6 Participants
Each participant received a single oral dose of 10 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 20 mg
n=6 Participants
Each participant received a single oral dose of 20 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 40 mg
n=6 Participants
Each participant received a single oral dose of 40 mg of ATH-399A.
|
Part 2 (MAD): Placebo
n=6 Participants
Each participant received a single dose of matching placebo.
|
Part 1a (SAD): ATH-399A 5 mg
n=6 Participants
Each participant received a single oral dose of 5 mg of ATH-399A.
|
Part 2 (MAD): ATH-399A 20 mg
n=6 Participants
Each participant received ATH-399A 20 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
Part 2 (MAD): ATH-399A 40 mg
n=6 Participants
Each participant received ATH-399A 40 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
Part 2 (MAD): ATH-399A 40 mg, Older
n=6 Participants
Each participant aged \>55-80 years received ATH-399A 40 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Physical Examination and Neurological Examination Abnormalities Analysis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Part 1a, 1b: D1, D2, D3; Part 2: D1, D2, D12, D13 (Discharge or early termination)Participants with abnormal findings on 12-lead telemetry (pooled data from the whole study)
Outcome measures
| Measure |
Part 1b (Food Effect): ATH-399A 40 mg, Fed
n=12 Participants
ATH-399A 40 mg was administered following a high-fat, high-calorie meal.
|
Part 1b (Food Effect): ATH-399A 40 mg, Fasted
n=8 Participants
Participants were restricted from eating 10 hours prior to and 4 hours following ATH-399A 40 mg administration.
|
Part 1b (Food Effect): ATH-399A 40 mg, Fed
n=10 Participants
ATH-399A 40 mg was administered following a high-fat, high-calorie meal.
|
Part 1a (SAD): ATH-399A 80 mg
n=6 Participants
Each participant received a single oral dose of 80 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 10 mg
n=6 Participants
Each participant received a single oral dose of 10 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 20 mg
n=6 Participants
Each participant received a single oral dose of 20 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 40 mg
n=6 Participants
Each participant received a single oral dose of 40 mg of ATH-399A.
|
Part 2 (MAD): Placebo
n=6 Participants
Each participant received a single dose of matching placebo.
|
Part 1a (SAD): ATH-399A 5 mg
n=6 Participants
Each participant received a single oral dose of 5 mg of ATH-399A.
|
Part 2 (MAD): ATH-399A 20 mg
n=6 Participants
Each participant received ATH-399A 20 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
Part 2 (MAD): ATH-399A 40 mg
n=6 Participants
Each participant received ATH-399A 40 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
Part 2 (MAD): ATH-399A 40 mg, Older
n=6 Participants
Each participant aged \>55-80 years received ATH-399A 40 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
12-Lead Telemetry Abnormalities Analysis
|
5 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Day 1Laboratory parameter: Creatinine level on Day 1
Outcome measures
| Measure |
Part 1b (Food Effect): ATH-399A 40 mg, Fed
n=12 Participants
ATH-399A 40 mg was administered following a high-fat, high-calorie meal.
|
Part 1b (Food Effect): ATH-399A 40 mg, Fasted
n=8 Participants
Participants were restricted from eating 10 hours prior to and 4 hours following ATH-399A 40 mg administration.
|
Part 1b (Food Effect): ATH-399A 40 mg, Fed
n=10 Participants
ATH-399A 40 mg was administered following a high-fat, high-calorie meal.
|
Part 1a (SAD): ATH-399A 80 mg
n=6 Participants
Each participant received a single oral dose of 80 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 10 mg
n=6 Participants
Each participant received a single oral dose of 10 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 20 mg
n=6 Participants
Each participant received a single oral dose of 20 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 40 mg
n=6 Participants
Each participant received a single oral dose of 40 mg of ATH-399A.
|
Part 2 (MAD): Placebo
n=6 Participants
Each participant received a single dose of matching placebo.
|
Part 1a (SAD): ATH-399A 5 mg
n=6 Participants
Each participant received a single oral dose of 5 mg of ATH-399A.
|
Part 2 (MAD): ATH-399A 20 mg
n=6 Participants
Each participant received ATH-399A 20 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
Part 2 (MAD): ATH-399A 40 mg
n=6 Participants
Each participant received ATH-399A 40 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
Part 2 (MAD): ATH-399A 40 mg, Older
n=6 Participants
Each participant aged \>55-80 years received ATH-399A 40 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Laboratory Parameter: Creatinine Value
|
76.5 μmol/L
Standard Deviation 15.26
|
76.4 μmol/L
Standard Deviation 16.37
|
76.6 μmol/L
Standard Deviation 10.86
|
70.2 μmol/L
Standard Deviation 9.06
|
78.5 μmol/L
Standard Deviation 19.95
|
64.8 μmol/L
Standard Deviation 13.27
|
88.3 μmol/L
Standard Deviation 8.02
|
87.3 μmol/L
Standard Deviation 14.96
|
79.2 μmol/L
Standard Deviation 16.87
|
87.5 μmol/L
Standard Deviation 14.46
|
111.2 μmol/L
Standard Deviation 15.43
|
84.0 μmol/L
Standard Deviation 11.24
|
PRIMARY outcome
Timeframe: Day 1Laboratory parameter: Glucose level measured on Day 1
Outcome measures
| Measure |
Part 1b (Food Effect): ATH-399A 40 mg, Fed
n=12 Participants
ATH-399A 40 mg was administered following a high-fat, high-calorie meal.
|
Part 1b (Food Effect): ATH-399A 40 mg, Fasted
n=8 Participants
Participants were restricted from eating 10 hours prior to and 4 hours following ATH-399A 40 mg administration.
|
Part 1b (Food Effect): ATH-399A 40 mg, Fed
n=10 Participants
ATH-399A 40 mg was administered following a high-fat, high-calorie meal.
|
Part 1a (SAD): ATH-399A 80 mg
n=6 Participants
Each participant received a single oral dose of 80 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 10 mg
n=6 Participants
Each participant received a single oral dose of 10 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 20 mg
n=6 Participants
Each participant received a single oral dose of 20 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 40 mg
n=6 Participants
Each participant received a single oral dose of 40 mg of ATH-399A.
|
Part 2 (MAD): Placebo
n=6 Participants
Each participant received a single dose of matching placebo.
|
Part 1a (SAD): ATH-399A 5 mg
n=6 Participants
Each participant received a single oral dose of 5 mg of ATH-399A.
|
Part 2 (MAD): ATH-399A 20 mg
n=6 Participants
Each participant received ATH-399A 20 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
Part 2 (MAD): ATH-399A 40 mg
n=6 Participants
Each participant received ATH-399A 40 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
Part 2 (MAD): ATH-399A 40 mg, Older
n=6 Participants
Each participant aged \>55-80 years received ATH-399A 40 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Laboratory Parameter: Glucose
|
4.95 mmol/L
Standard Deviation 0.894
|
4.84 mmol/L
Standard Deviation 0.907
|
4.04 mmol/L
Standard Deviation 0.782
|
4.23 mmol/L
Standard Deviation 0.779
|
4.07 mmol/L
Standard Deviation 0.585
|
4.16 mmol/L
Standard Deviation 0.657
|
4.62 mmol/L
Standard Deviation 0.983
|
4.58 mmol/L
Standard Deviation 0.313
|
4.35 mmol/L
Standard Deviation 0.797
|
4.43 mmol/L
Standard Deviation 0.441
|
4.43 mmol/L
Standard Deviation 0.568
|
3.85 mmol/L
Standard Deviation 0.356
|
SECONDARY outcome
Timeframe: Part 1: Day 1 Pre-dose (within 2 hours of dosing) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours. Part 2: Day 12 Pre-dose (within 2 hours of dosing) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours.Plasma Pharmacokinetic (PK) parameter: Area Under the Concentration-Time Curve from Time Zero Until the Last Observed Concentration (AUC0-t) for Part 1a, Part 1b and Part 2. AUC0-t was calculated based on several PK blood sampling at times provided in the Outcome Measure Time Frame.
Outcome measures
| Measure |
Part 1b (Food Effect): ATH-399A 40 mg, Fed
n=8 Participants
ATH-399A 40 mg was administered following a high-fat, high-calorie meal.
|
Part 1b (Food Effect): ATH-399A 40 mg, Fasted
n=6 Participants
Participants were restricted from eating 10 hours prior to and 4 hours following ATH-399A 40 mg administration.
|
Part 1b (Food Effect): ATH-399A 40 mg, Fed
n=12 Participants
ATH-399A 40 mg was administered following a high-fat, high-calorie meal.
|
Part 1a (SAD): ATH-399A 80 mg
n=6 Participants
Each participant received a single oral dose of 80 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 10 mg
n=6 Participants
Each participant received a single oral dose of 10 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 20 mg
n=6 Participants
Each participant received a single oral dose of 20 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 40 mg
n=6 Participants
Each participant received a single oral dose of 40 mg of ATH-399A.
|
Part 2 (MAD): Placebo
Each participant received a single dose of matching placebo.
|
Part 1a (SAD): ATH-399A 5 mg
n=6 Participants
Each participant received a single oral dose of 5 mg of ATH-399A.
|
Part 2 (MAD): ATH-399A 20 mg
n=6 Participants
Each participant received ATH-399A 20 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
Part 2 (MAD): ATH-399A 40 mg
n=6 Participants
Each participant received ATH-399A 40 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
Part 2 (MAD): ATH-399A 40 mg, Older
Each participant aged \>55-80 years received ATH-399A 40 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC0-t
|
569.69 h*ng/mL
Standard Deviation 189.58
|
450.52 h*ng/mL
Standard Deviation 124.54
|
651.13 h*ng/mL
Standard Deviation 179.31
|
1093.98 h*ng/mL
Standard Deviation 274.05
|
53.71 h*ng/mL
Standard Deviation 30.15
|
168.62 h*ng/mL
Standard Deviation 73.85
|
481.81 h*ng/mL
Standard Deviation 171.08
|
—
|
34.19 h*ng/mL
Standard Deviation 8.34
|
1337.49 h*ng/mL
Standard Deviation 577.26
|
1601.07 h*ng/mL
Standard Deviation 476.59
|
—
|
SECONDARY outcome
Timeframe: Part 1: Day 1 Pre-dose (within 2 hours of dosing) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours. Part 2: Day 12 Pre-dose (within 2 hours of dosing) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours.PK parameter: Area Under The Concentration-Time Curve From Time Zero To Infinity (Extrapolated) (AUC0-inf) for Part 1a, Part 1b and Part 2. AUC0-inf was calculated based on several PK blood sampling at times provided in the Outcome Measure Time Frame.
Outcome measures
| Measure |
Part 1b (Food Effect): ATH-399A 40 mg, Fed
n=8 Participants
ATH-399A 40 mg was administered following a high-fat, high-calorie meal.
|
Part 1b (Food Effect): ATH-399A 40 mg, Fasted
n=6 Participants
Participants were restricted from eating 10 hours prior to and 4 hours following ATH-399A 40 mg administration.
|
Part 1b (Food Effect): ATH-399A 40 mg, Fed
n=12 Participants
ATH-399A 40 mg was administered following a high-fat, high-calorie meal.
|
Part 1a (SAD): ATH-399A 80 mg
n=6 Participants
Each participant received a single oral dose of 80 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 10 mg
n=6 Participants
Each participant received a single oral dose of 10 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 20 mg
n=6 Participants
Each participant received a single oral dose of 20 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 40 mg
n=6 Participants
Each participant received a single oral dose of 40 mg of ATH-399A.
|
Part 2 (MAD): Placebo
Each participant received a single dose of matching placebo.
|
Part 1a (SAD): ATH-399A 5 mg
n=6 Participants
Each participant received a single oral dose of 5 mg of ATH-399A.
|
Part 2 (MAD): ATH-399A 20 mg
n=5 Participants
Each participant received ATH-399A 20 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
Part 2 (MAD): ATH-399A 40 mg
n=4 Participants
Each participant received ATH-399A 40 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
Part 2 (MAD): ATH-399A 40 mg, Older
Each participant aged \>55-80 years received ATH-399A 40 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC0-inf
|
625.05 h*ng/mL
Standard Deviation 209.54
|
485.14 h*ng/mL
Standard Deviation 134.00
|
720.93 h*ng/mL
Standard Deviation 211.31
|
1200.69 h*ng/mL
Standard Deviation 320.04
|
86.22 h*ng/mL
Standard Deviation 32.59
|
212.02 h*ng/mL
Standard Deviation 95.27
|
522.19 h*ng/mL
Standard Deviation 172.75
|
—
|
45.92 h*ng/mL
Standard Deviation 9.28
|
1454.58 h*ng/mL
Standard Deviation 629.97
|
1782.88 h*ng/mL
Standard Deviation 504.10
|
—
|
SECONDARY outcome
Timeframe: Part 1: Day 1 Pre-dose (within 2 hours of dosing) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours. Part 2: Day 1 Pre-dose (within 2 hours of dosing) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours.PK parameter: Maximal Observed Concentration (Cmax) for Part 1a, Part 1b and Part 2. Cmax was calculated based on several PK blood sampling at times provided in the Outcome Measure Time Frame.
Outcome measures
| Measure |
Part 1b (Food Effect): ATH-399A 40 mg, Fed
n=8 Participants
ATH-399A 40 mg was administered following a high-fat, high-calorie meal.
|
Part 1b (Food Effect): ATH-399A 40 mg, Fasted
n=6 Participants
Participants were restricted from eating 10 hours prior to and 4 hours following ATH-399A 40 mg administration.
|
Part 1b (Food Effect): ATH-399A 40 mg, Fed
n=12 Participants
ATH-399A 40 mg was administered following a high-fat, high-calorie meal.
|
Part 1a (SAD): ATH-399A 80 mg
n=6 Participants
Each participant received a single oral dose of 80 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 10 mg
n=6 Participants
Each participant received a single oral dose of 10 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 20 mg
n=6 Participants
Each participant received a single oral dose of 20 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 40 mg
n=6 Participants
Each participant received a single oral dose of 40 mg of ATH-399A.
|
Part 2 (MAD): Placebo
Each participant received a single dose of matching placebo.
|
Part 1a (SAD): ATH-399A 5 mg
n=6 Participants
Each participant received a single oral dose of 5 mg of ATH-399A.
|
Part 2 (MAD): ATH-399A 20 mg
n=6 Participants
Each participant received ATH-399A 20 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
Part 2 (MAD): ATH-399A 40 mg
n=6 Participants
Each participant received ATH-399A 40 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
Part 2 (MAD): ATH-399A 40 mg, Older
Each participant aged \>55-80 years received ATH-399A 40 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax
|
22.49 ng/mL
Standard Deviation 11.58
|
5.32 ng/mL
Standard Deviation 2.46
|
22.50 ng/mL
Standard Deviation 7.90
|
45.40 ng/mL
Standard Deviation 14.51
|
1.93 ng/mL
Standard Deviation 1.03
|
9.11 ng/mL
Standard Deviation 5.28
|
20.57 ng/mL
Standard Deviation 11.95
|
—
|
1.53 ng/mL
Standard Deviation 0.55
|
14.21 ng/mL
Standard Deviation 10.64
|
13.78 ng/mL
Standard Deviation 10.23
|
—
|
SECONDARY outcome
Timeframe: Part 1: Day 1 Pre-dose (within 2 hours of dosing) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours. Part 2: Day 1 Pre-dose (within 2 hours of dosing) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours.PK parameter: Time When The Maximal Concentration Is Observed (Tmax) for Part 1a, Part 1b and Part 2. Tmax was calculated based on several PK blood sampling at times provided in the Outcome Measure Time Frame.
Outcome measures
| Measure |
Part 1b (Food Effect): ATH-399A 40 mg, Fed
n=8 Participants
ATH-399A 40 mg was administered following a high-fat, high-calorie meal.
|
Part 1b (Food Effect): ATH-399A 40 mg, Fasted
n=6 Participants
Participants were restricted from eating 10 hours prior to and 4 hours following ATH-399A 40 mg administration.
|
Part 1b (Food Effect): ATH-399A 40 mg, Fed
n=12 Participants
ATH-399A 40 mg was administered following a high-fat, high-calorie meal.
|
Part 1a (SAD): ATH-399A 80 mg
n=6 Participants
Each participant received a single oral dose of 80 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 10 mg
n=6 Participants
Each participant received a single oral dose of 10 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 20 mg
n=6 Participants
Each participant received a single oral dose of 20 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 40 mg
n=6 Participants
Each participant received a single oral dose of 40 mg of ATH-399A.
|
Part 2 (MAD): Placebo
Each participant received a single dose of matching placebo.
|
Part 1a (SAD): ATH-399A 5 mg
n=6 Participants
Each participant received a single oral dose of 5 mg of ATH-399A.
|
Part 2 (MAD): ATH-399A 20 mg
n=6 Participants
Each participant received ATH-399A 20 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
Part 2 (MAD): ATH-399A 40 mg
n=6 Participants
Each participant received ATH-399A 40 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
Part 2 (MAD): ATH-399A 40 mg, Older
Each participant aged \>55-80 years received ATH-399A 40 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tmax
|
4 hours
Interval 2.0 to 12.0
|
5.009 hours
Interval 2.0 to 12.0
|
6.009 hours
Interval 4.0 to 16.0
|
7 hours
Interval 3.0 to 8.0
|
8.009 hours
Interval 6.0 to 12.0
|
4.500 hours
Interval 2.0 to 8.0
|
4.059 hours
Interval 3.0 to 8.017
|
—
|
7 hours
Interval 2.0 to 12.0
|
7 hours
Interval 4.0 to 8.017
|
8.017 hours
Interval 2.0 to 23.517
|
—
|
SECONDARY outcome
Timeframe: Part 1: Day 1 Pre-dose (within 2 hours of dosing) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours. Part 2: Day 12 Pre-dose (within 2 hours of dosing) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours.PK parameter: Individual Estimate Of The Terminal Elimination Rate Constant (λz) for Part 1a, Part 1b and Part 2. λz was calculated based on several PK blood sampling at times provided in the Outcome Measure Time Frame.
Outcome measures
| Measure |
Part 1b (Food Effect): ATH-399A 40 mg, Fed
n=8 Participants
ATH-399A 40 mg was administered following a high-fat, high-calorie meal.
|
Part 1b (Food Effect): ATH-399A 40 mg, Fasted
n=6 Participants
Participants were restricted from eating 10 hours prior to and 4 hours following ATH-399A 40 mg administration.
|
Part 1b (Food Effect): ATH-399A 40 mg, Fed
n=12 Participants
ATH-399A 40 mg was administered following a high-fat, high-calorie meal.
|
Part 1a (SAD): ATH-399A 80 mg
n=6 Participants
Each participant received a single oral dose of 80 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 10 mg
n=5 Participants
Each participant received a single oral dose of 10 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 20 mg
n=6 Participants
Each participant received a single oral dose of 20 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 40 mg
n=6 Participants
Each participant received a single oral dose of 40 mg of ATH-399A.
|
Part 2 (MAD): Placebo
Each participant received a single dose of matching placebo.
|
Part 1a (SAD): ATH-399A 5 mg
n=6 Participants
Each participant received a single oral dose of 5 mg of ATH-399A.
|
Part 2 (MAD): ATH-399A 20 mg
n=5 Participants
Each participant received ATH-399A 20 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
Part 2 (MAD): ATH-399A 40 mg
n=4 Participants
Each participant received ATH-399A 40 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
Part 2 (MAD): ATH-399A 40 mg, Older
Each participant aged \>55-80 years received ATH-399A 40 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
λz
|
0.0261 1/hr
Standard Deviation 0.0047
|
0.0286 1/hr
Standard Deviation 0.0041
|
0.0253 1/hr
Standard Deviation 0.0052
|
0.0250 1/hr
Standard Deviation 0.0041
|
0.0308 1/hr
Standard Deviation 0.0062
|
0.0363 1/hr
Standard Deviation 0.0069
|
0.0269 1/hr
Standard Deviation 0.0057
|
—
|
0.0304 1/hr
Standard Deviation 0.0081
|
0.0264 1/hr
Standard Deviation 0.0026
|
0.0235 1/hr
Standard Deviation 0.0028
|
—
|
SECONDARY outcome
Timeframe: Part 1: Day 1 Pre-dose (within 2 hours of dosing) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours. Part 2: Day 12 Pre-dose (within 2 hours of dosing) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours.PK parameter: Terminal Elimination Half-Life (t½ el) for Part 1a, Part 1b and Part 2. T1/2 el was calculated based on several PK blood sampling at times provided in the Outcome Measure Time Frame.
Outcome measures
| Measure |
Part 1b (Food Effect): ATH-399A 40 mg, Fed
n=8 Participants
ATH-399A 40 mg was administered following a high-fat, high-calorie meal.
|
Part 1b (Food Effect): ATH-399A 40 mg, Fasted
n=6 Participants
Participants were restricted from eating 10 hours prior to and 4 hours following ATH-399A 40 mg administration.
|
Part 1b (Food Effect): ATH-399A 40 mg, Fed
n=12 Participants
ATH-399A 40 mg was administered following a high-fat, high-calorie meal.
|
Part 1a (SAD): ATH-399A 80 mg
n=6 Participants
Each participant received a single oral dose of 80 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 10 mg
n=5 Participants
Each participant received a single oral dose of 10 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 20 mg
n=6 Participants
Each participant received a single oral dose of 20 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 40 mg
n=6 Participants
Each participant received a single oral dose of 40 mg of ATH-399A.
|
Part 2 (MAD): Placebo
Each participant received a single dose of matching placebo.
|
Part 1a (SAD): ATH-399A 5 mg
n=6 Participants
Each participant received a single oral dose of 5 mg of ATH-399A.
|
Part 2 (MAD): ATH-399A 20 mg
n=5 Participants
Each participant received ATH-399A 20 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
Part 2 (MAD): ATH-399A 40 mg
n=4 Participants
Each participant received ATH-399A 40 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
Part 2 (MAD): ATH-399A 40 mg, Older
Each participant aged \>55-80 years received ATH-399A 40 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
t½ el
|
27.32 hours
Standard Deviation 4.82
|
24.63 hours
Standard Deviation 3.28
|
28.48 hours
Standard Deviation 5.62
|
28.31 hours
Standard Deviation 4.65
|
23.32 hours
Standard Deviation 4.96
|
19.71 hours
Standard Deviation 4.01
|
26.77 hours
Standard Deviation 5.59
|
—
|
23.86 hours
Standard Deviation 4.80
|
26.44 hours
Standard Deviation 2.59
|
29.85 hours
Standard Deviation 3.44
|
—
|
SECONDARY outcome
Timeframe: Part 2 only: Day 12 Pre-dose (within 2 hours of dosing) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours.Population: Cmax ss has been analyzed only in patients included in Part 2
PK parameter: Maximal Observed Concentration at steady state (Cmax, ss) for Part 2. Cmax,ss was calculated based on several PK blood sampling at times provided in the Outcome Measure Time Frame.
Outcome measures
| Measure |
Part 1b (Food Effect): ATH-399A 40 mg, Fed
ATH-399A 40 mg was administered following a high-fat, high-calorie meal.
|
Part 1b (Food Effect): ATH-399A 40 mg, Fasted
Participants were restricted from eating 10 hours prior to and 4 hours following ATH-399A 40 mg administration.
|
Part 1b (Food Effect): ATH-399A 40 mg, Fed
ATH-399A 40 mg was administered following a high-fat, high-calorie meal.
|
Part 1a (SAD): ATH-399A 80 mg
Each participant received a single oral dose of 80 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 10 mg
n=5 Participants
Each participant received a single oral dose of 10 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 20 mg
n=4 Participants
Each participant received a single oral dose of 20 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 40 mg
Each participant received a single oral dose of 40 mg of ATH-399A.
|
Part 2 (MAD): Placebo
Each participant received a single dose of matching placebo.
|
Part 1a (SAD): ATH-399A 5 mg
n=6 Participants
Each participant received a single oral dose of 5 mg of ATH-399A.
|
Part 2 (MAD): ATH-399A 20 mg
Each participant received ATH-399A 20 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
Part 2 (MAD): ATH-399A 40 mg
Each participant received ATH-399A 40 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
Part 2 (MAD): ATH-399A 40 mg, Older
Each participant aged \>55-80 years received ATH-399A 40 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax, ss
|
—
|
—
|
—
|
—
|
51.88 ng/mL
Standard Deviation 34.86
|
46.04 ng/mL
Standard Deviation 21.52
|
—
|
—
|
14.98 ng/mL
Standard Deviation 6.89
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part 2 only: Day 12 Pre-dose (within 2 hours of dosing) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hoursPK parameter: Minimal Observed Concentration at steady-state (Cmin ss) for Part 2. Cmin was calculated based on several PK blood sampling at times provided in the Outcome Measure Time Frame.
Outcome measures
| Measure |
Part 1b (Food Effect): ATH-399A 40 mg, Fed
ATH-399A 40 mg was administered following a high-fat, high-calorie meal.
|
Part 1b (Food Effect): ATH-399A 40 mg, Fasted
Participants were restricted from eating 10 hours prior to and 4 hours following ATH-399A 40 mg administration.
|
Part 1b (Food Effect): ATH-399A 40 mg, Fed
ATH-399A 40 mg was administered following a high-fat, high-calorie meal.
|
Part 1a (SAD): ATH-399A 80 mg
Each participant received a single oral dose of 80 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 10 mg
n=5 Participants
Each participant received a single oral dose of 10 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 20 mg
n=4 Participants
Each participant received a single oral dose of 20 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 40 mg
Each participant received a single oral dose of 40 mg of ATH-399A.
|
Part 2 (MAD): Placebo
Each participant received a single dose of matching placebo.
|
Part 1a (SAD): ATH-399A 5 mg
n=6 Participants
Each participant received a single oral dose of 5 mg of ATH-399A.
|
Part 2 (MAD): ATH-399A 20 mg
Each participant received ATH-399A 20 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
Part 2 (MAD): ATH-399A 40 mg
Each participant received ATH-399A 40 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
Part 2 (MAD): ATH-399A 40 mg, Older
Each participant aged \>55-80 years received ATH-399A 40 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cmin ss
|
—
|
—
|
—
|
—
|
17.91 ng/mL
Standard Deviation 6.87
|
20.39 ng/mL
Standard Deviation 6.89
|
—
|
—
|
6.25 ng/mL
Standard Deviation 2.16
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part 2 only: Day 12 Pre-dose (within 2 hours of dosing) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours.PK parameter: Average Plasma Concentration (Cavg) for Part 2. Cavg was calculated based on several PK blood sampling at times provided in the Outcome Measure Time Frame.
Outcome measures
| Measure |
Part 1b (Food Effect): ATH-399A 40 mg, Fed
ATH-399A 40 mg was administered following a high-fat, high-calorie meal.
|
Part 1b (Food Effect): ATH-399A 40 mg, Fasted
Participants were restricted from eating 10 hours prior to and 4 hours following ATH-399A 40 mg administration.
|
Part 1b (Food Effect): ATH-399A 40 mg, Fed
ATH-399A 40 mg was administered following a high-fat, high-calorie meal.
|
Part 1a (SAD): ATH-399A 80 mg
Each participant received a single oral dose of 80 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 10 mg
n=5 Participants
Each participant received a single oral dose of 10 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 20 mg
n=4 Participants
Each participant received a single oral dose of 20 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 40 mg
Each participant received a single oral dose of 40 mg of ATH-399A.
|
Part 2 (MAD): Placebo
Each participant received a single dose of matching placebo.
|
Part 1a (SAD): ATH-399A 5 mg
n=6 Participants
Each participant received a single oral dose of 5 mg of ATH-399A.
|
Part 2 (MAD): ATH-399A 20 mg
Each participant received ATH-399A 20 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
Part 2 (MAD): ATH-399A 40 mg
Each participant received ATH-399A 40 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
Part 2 (MAD): ATH-399A 40 mg, Older
Each participant aged \>55-80 years received ATH-399A 40 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cavg
|
—
|
—
|
—
|
—
|
30.21 ng/mL
Standard Deviation 14.42
|
32.28 ng/mL
Standard Deviation 12.42
|
—
|
—
|
10.47 ng/mL
Standard Deviation 3.41
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part 2 only: Day 12 Pre-dose (within 2 hours of dosing) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours.PK parameter: Time When The Maximal Concentration Is Observed at Steady State (Tmax, ss) for Part 2. Tmax, ss was calculated based on several PK blood sampling at times provided in the Outcome Measure Time Frame.
Outcome measures
| Measure |
Part 1b (Food Effect): ATH-399A 40 mg, Fed
ATH-399A 40 mg was administered following a high-fat, high-calorie meal.
|
Part 1b (Food Effect): ATH-399A 40 mg, Fasted
Participants were restricted from eating 10 hours prior to and 4 hours following ATH-399A 40 mg administration.
|
Part 1b (Food Effect): ATH-399A 40 mg, Fed
ATH-399A 40 mg was administered following a high-fat, high-calorie meal.
|
Part 1a (SAD): ATH-399A 80 mg
Each participant received a single oral dose of 80 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 10 mg
n=5 Participants
Each participant received a single oral dose of 10 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 20 mg
n=4 Participants
Each participant received a single oral dose of 20 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 40 mg
Each participant received a single oral dose of 40 mg of ATH-399A.
|
Part 2 (MAD): Placebo
Each participant received a single dose of matching placebo.
|
Part 1a (SAD): ATH-399A 5 mg
n=6 Participants
Each participant received a single oral dose of 5 mg of ATH-399A.
|
Part 2 (MAD): ATH-399A 20 mg
Each participant received ATH-399A 20 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
Part 2 (MAD): ATH-399A 40 mg
Each participant received ATH-399A 40 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
Part 2 (MAD): ATH-399A 40 mg, Older
Each participant aged \>55-80 years received ATH-399A 40 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tmax, ss
|
—
|
—
|
—
|
—
|
4 hours
Interval 3.0 to 12.0
|
5.5 hours
Interval 1.0 to 24.0
|
—
|
—
|
5 hours
Interval 4.0 to 8.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part 2 only: Day 12 Pre-dose (within 2 hours of dosing) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours.PK parameter: Area Under The Concentration-Time Curve For One Dosing Interval (Τ) (AUC0-τ) \[i.e., AUC0-24 on Day 12 dose\] for Part 2 only. Value was calculated based on several PK blood sampling at times provided in the Outcome Measure Time Frame.
Outcome measures
| Measure |
Part 1b (Food Effect): ATH-399A 40 mg, Fed
ATH-399A 40 mg was administered following a high-fat, high-calorie meal.
|
Part 1b (Food Effect): ATH-399A 40 mg, Fasted
Participants were restricted from eating 10 hours prior to and 4 hours following ATH-399A 40 mg administration.
|
Part 1b (Food Effect): ATH-399A 40 mg, Fed
ATH-399A 40 mg was administered following a high-fat, high-calorie meal.
|
Part 1a (SAD): ATH-399A 80 mg
Each participant received a single oral dose of 80 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 10 mg
n=5 Participants
Each participant received a single oral dose of 10 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 20 mg
n=4 Participants
Each participant received a single oral dose of 20 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 40 mg
Each participant received a single oral dose of 40 mg of ATH-399A.
|
Part 2 (MAD): Placebo
Each participant received a single dose of matching placebo.
|
Part 1a (SAD): ATH-399A 5 mg
n=6 Participants
Each participant received a single oral dose of 5 mg of ATH-399A.
|
Part 2 (MAD): ATH-399A 20 mg
Each participant received ATH-399A 20 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
Part 2 (MAD): ATH-399A 40 mg
Each participant received ATH-399A 40 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
Part 2 (MAD): ATH-399A 40 mg, Older
Each participant aged \>55-80 years received ATH-399A 40 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC0-τ (AUC0-24 at Day 12 Dose) for Part 2
|
—
|
—
|
—
|
—
|
725.06 h*ng/mL
Standard Deviation 345.98
|
774.81 h*ng/mL
Standard Deviation 298.05
|
—
|
—
|
251.24 h*ng/mL
Standard Deviation 81.96
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part 2 only: Day 1 Pre-dose (within 2 hours of dosing) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours.PK parameter: Area Under The Concentration-Time Curve AUC0-t (i.e., AUC0-24 on Day 1 dose only) for Part 2
Outcome measures
| Measure |
Part 1b (Food Effect): ATH-399A 40 mg, Fed
ATH-399A 40 mg was administered following a high-fat, high-calorie meal.
|
Part 1b (Food Effect): ATH-399A 40 mg, Fasted
Participants were restricted from eating 10 hours prior to and 4 hours following ATH-399A 40 mg administration.
|
Part 1b (Food Effect): ATH-399A 40 mg, Fed
ATH-399A 40 mg was administered following a high-fat, high-calorie meal.
|
Part 1a (SAD): ATH-399A 80 mg
Each participant received a single oral dose of 80 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 10 mg
n=6 Participants
Each participant received a single oral dose of 10 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 20 mg
n=6 Participants
Each participant received a single oral dose of 20 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 40 mg
Each participant received a single oral dose of 40 mg of ATH-399A.
|
Part 2 (MAD): Placebo
Each participant received a single dose of matching placebo.
|
Part 1a (SAD): ATH-399A 5 mg
n=6 Participants
Each participant received a single oral dose of 5 mg of ATH-399A.
|
Part 2 (MAD): ATH-399A 20 mg
Each participant received ATH-399A 20 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
Part 2 (MAD): ATH-399A 40 mg
Each participant received ATH-399A 40 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
Part 2 (MAD): ATH-399A 40 mg, Older
Each participant aged \>55-80 years received ATH-399A 40 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC0-t on Day 1 Dose for Part 2
|
—
|
—
|
—
|
—
|
208.14 h*ng/mL
Standard Deviation 126.00
|
186.80 h*ng/mL
Standard Deviation 88.77
|
—
|
—
|
83.99 h*ng/mL
Standard Deviation 34.09
|
—
|
—
|
—
|
Adverse Events
Part 1a (SAD): ATH-399A 5 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 1a (SAD): ATH-399A 10 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 1a (SAD): ATH-399A 20 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 1a (SAD): ATH-399A 40 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1a (SAD): ATH-399A 80 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 1a (SAD): Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1b (Food Effect): ATH-399A 40 mg, Fed
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1b (Food Effect): ATH-399A 40 mg, Fasted
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 2 (MAD): ATH-399A 20 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 2 (MAD): ATH-399A 40 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 2 (MAD): ATH-399A 40 mg, Older
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 2 (MAD): Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 1a (SAD): ATH-399A 5 mg
n=6 participants at risk
Each participant received a single oral dose of 5 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 10 mg
n=6 participants at risk
Each participant received a single oral dose of 10 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 20 mg
n=6 participants at risk
Each participant received a single oral dose of 20 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 40 mg
n=6 participants at risk
Each participant received a single oral dose of 40 mg of ATH-399A.
|
Part 1a (SAD): ATH-399A 80 mg
n=6 participants at risk
Each participant received a single oral dose of 80 mg of ATH-399A.
|
Part 1a (SAD): Placebo
n=10 participants at risk
Each participant received a single dose of matching placebo.
|
Part 1b (Food Effect): ATH-399A 40 mg, Fed
n=12 participants at risk
ATH-399A 40 mg was administered following a high-fat, high-calorie meal.
|
Part 1b (Food Effect): ATH-399A 40 mg, Fasted
n=8 participants at risk
Participants were restricted from eating 10 hours prior to and 4 hours following ATH-399A 40 mg administration.
|
Part 2 (MAD): ATH-399A 20 mg
n=6 participants at risk
Each participant received ATH-399A 20 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
Part 2 (MAD): ATH-399A 40 mg
n=6 participants at risk
Each participant received ATH-399A 40 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
Part 2 (MAD): ATH-399A 40 mg, Older
n=6 participants at risk
Each participant aged \>55-80 years received ATH-399A 40 mg once daily from Day 1 to Day 12. Participants underwent a supervised fast for at least 10 hours prior to dosing, followed by an additional 4 hours of fasting post-dose.
|
Part 2 (MAD): Placebo
n=6 participants at risk
Each participant received a single dose of matching placebo.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Presyncope, headache
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/10 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
8.3%
1/12 • Number of events 1 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/8 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
16.7%
1/6 • Number of events 1 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
|
Infections and infestations
COVID-19, conjunctivitis, asymptomatic bacteriuria, nasopharyngitis
|
16.7%
1/6 • Number of events 1 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
16.7%
1/6 • Number of events 1 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
16.7%
1/6 • Number of events 1 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/10 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/12 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
12.5%
1/8 • Number of events 1 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
16.7%
1/6 • Number of events 1 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
16.7%
1/6 • Number of events 1 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion, nasal dryness, oropharyngeal pain, hiccups
|
16.7%
1/6 • Number of events 1 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
16.7%
1/6 • Number of events 1 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
16.7%
1/6 • Number of events 1 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/10 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/12 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/8 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
16.7%
1/6 • Number of events 1 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
|
Investigations
Blood pressure decreased, blood pressure increased, blood creatine phosphokinase increased, electroc
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
16.7%
1/6 • Number of events 1 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
16.7%
1/6 • Number of events 1 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
20.0%
2/10 • Number of events 3 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
8.3%
1/12 • Number of events 1 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/8 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
16.7%
1/6 • Number of events 1 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
16.7%
1/6 • Number of events 1 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
33.3%
2/6 • Number of events 2 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
|
Cardiac disorders
Accelerated idioventricular rhythm, ventricular tachycardia
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
16.7%
1/6 • Number of events 1 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/10 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
8.3%
1/12 • Number of events 1 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/8 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
16.7%
1/6 • Number of events 1 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
|
Eye disorders
Abnormal sensation in eye, conjunctival hyperaemia
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
16.7%
1/6 • Number of events 1 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/10 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/12 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/8 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
16.7%
1/6 • Number of events 1 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
|
Gastrointestinal disorders
Dry mouth, abdominal discomfort, constipation, abdominal pain
|
16.7%
1/6 • Number of events 1 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/10 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/12 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/8 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
16.7%
1/6 • Number of events 1 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
16.7%
1/6 • Number of events 2 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
16.7%
1/6 • Number of events 1 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
16.7%
1/6 • Number of events 1 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/10 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/12 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/8 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain, musculoskeletal chest pain, neck pain
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/10 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/12 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/8 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
16.7%
1/6 • Number of events 2 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
16.7%
1/6 • Number of events 2 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
|
General disorders
Fatigue
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/10 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/12 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/8 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
16.7%
1/6 • Number of events 1 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
|
Injury, poisoning and procedural complications
Lip injury
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/10 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/12 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/8 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
16.7%
1/6 • Number of events 1 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/10 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/12 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/8 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
16.7%
1/6 • Number of events 1 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
|
Vascular disorders
Hot flush
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/10 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/12 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/8 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/6 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
16.7%
1/6 • Number of events 1 • Continuously during study period from baseline to follow-up visit: Part 1a: Day-1 to Day 8, Part 1b: Day-1 to Day 16; and Part 2: Day -1 to Day 19
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
|
Additional Information
Sr. Director, Clinical Development Operations
HPI, Inc.
Phone: 301-738-3980
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER