Trial Outcomes & Findings for Phase 1 Study of TAK-831 in Healthy Adult Asian Subjects (NCT NCT03687684)
NCT ID: NCT03687684
Last Updated: 2021-06-14
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
40 participants
Primary outcome timeframe
Cohort 1: Baseline up to Day 23; Cohorts 2-5: Baseline up to Day 31
Results posted on
2021-06-14
Participant Flow
Participants took part in the study at single site in Japan from 09 October 2018 to 19 June 2019.
Healthy adult participants were randomized to receive TAK-831: under 3-sequential dose escalation design to the sequence of administration of A (100 mg +300 mg), B (100 mg + Placebo), and C (Placebo + 300 mg) in Cohort 1 (Japanese); single dose followed by multiple dose of TAK-831 or Placebo in Cohorts 2, 4, 5 (Japanese) and in Cohort 3 (Chinese).
Participant milestones
| Measure |
Japanese Cohort 1-A: TAK-831 100 mg + TAK-831 300 mg
TAK-831 100 milligram (mg), tablet, orally, once on Day 1 of Part 1, followed by TAK-831 300 mg, tablet, orally, once on Day 1 (Day 9) of Part 2 in healthy Japanese participants.
|
Japanese Cohort 1-B: TAK-831 100 mg + Placebo
TAK-831 100 mg, tablet, orally, once on Day 1 of Part 1 followed by TAK-831 matching placebo, tablet, orally, once on Day 1 (Day 9) of Part 2 in healthy Japanese participants.
|
Japanese Cohort 1-C: Placebo + TAK-831 300 mg
TAK-831 matching placebo, tablet, orally, once on Day 1 of Part 1 followed by TAK-831 300 mg, tablet, orally, once on Day 1 (Day 9) of Part 2 in healthy Japanese participants.
|
Japanese Cohort 2, 4 and 5: Pooled Placebo
TAK-831 matching placebo, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
|
Japanese Cohort 2: TAK-831 300 mg
TAK-831 300 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
|
Japanese Cohort 4: TAK-831 600 mg
TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
|
Japanese Cohort 5: TAK-831 50 mg
TAK-831 50 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
|
Chinese Cohort 3: Placebo
TAK-831 matching placebo, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Chinese participants.
|
Chinese Cohort 3: TAK-831 600 mg
TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Chinese participants.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
2
|
2
|
6
|
6
|
6
|
6
|
2
|
6
|
|
Overall Study
COMPLETED
|
4
|
2
|
2
|
6
|
6
|
6
|
6
|
2
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 1 Study of TAK-831 in Healthy Adult Asian Subjects
Baseline characteristics by cohort
| Measure |
Japanese Cohort 1-A: TAK-831 100 mg + TAK-831 300 mg
n=4 Participants
TAK-831 100 mg, tablet, orally, once on Day 1 of Part 1, followed by TAK-831 300 mg, tablet, orally, once on Day 1 (Day 9) of Part 2 in healthy Japanese participants.
|
Japanese Cohort 1-B: TAK-831 100 mg + Placebo
n=2 Participants
TAK-831 100 mg, tablet, orally, once on Day 1 of Part 1 followed by TAK-831 matching placebo, tablet, orally, once on Day 1 (Day 9) of Part 2 in healthy Japanese participants.
|
Japanese Cohort 1-C: Placebo + TAK-831 300 mg
n=2 Participants
TAK-831 matching placebo, tablet, orally, once on Day 1 of Part 1 followed by TAK-831 300 mg, tablet, orally, once on Day 1 (Day 9) of Part 2 in healthy Japanese participants.
|
Japanese Cohort 2, 4 and 5: Pooled Placebo
n=6 Participants
TAK-831 matching placebo, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
|
Japanese Cohort 2: TAK-831 300 mg
n=6 Participants
TAK-831 300 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
|
Japanese Cohort 4: TAK-831 600 mg
n=6 Participants
TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
|
Japanese Cohort 5: TAK-831 50 mg
n=6 Participants
TAK-831 50 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
|
Chinese Cohort 3: Placebo
n=2 Participants
TAK-831 matching placebo, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Chinese participants.
|
Chinese Cohort 3: TAK-831 600 mg
n=6 Participants
TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Chinese participants.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
40 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
40 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
40 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Region of Enrollment
Japan
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
40 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Cohort 1: Baseline up to Day 23; Cohorts 2-5: Baseline up to Day 31Population: The safety analysis set was defined as all participants who received at least one dose of study drug.
Outcome measures
| Measure |
Japanese Cohort 1: Placebo
n=4 Participants
TAK-831 matching placebo, tablets, orally, once on Day 1 of Part 1 and Day 1 (Day 9) of Part 2 in healthy Japanese participants.
|
Japanese Cohort 1: TAK-831 100 mg
n=6 Participants
TAK-831 100 mg, tablet, orally, once on Day 1 of Part 1 in healthy Japanese participants.
|
Japanese Cohort 1: TAK-831 300 mg
n=6 Participants
TAK-831 300 mg, tablet, orally, once on Day 1 (Day 9) of Part 2 in healthy Japanese participants.
|
Japanese Cohort 2, 4 and 5: Pooled Placebo
n=6 Participants
TAK-831 matching placebo, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
|
Japanese Cohort 2: TAK-831 300 mg
n=6 Participants
TAK-831 300 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
|
Japanese Cohort 4: TAK-831 600 mg
n=6 Participants
TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
|
Japanese Cohort 5: TAK-831 50 mg
n=6 Participants
TAK-831 50 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
|
Chinese Cohort 3: Placebo
n=2 Participants
TAK-831 matching placebo, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Chinese participants.
|
Chinese Cohort 3: TAK-831 600 mg
n=6 Participants
TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Chinese participants.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting at Least One Treatment-emergent Adverse Event (TEAE)
|
0 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Cohort 1: Baseline up to Day 23; Cohorts 2-5: Baseline up to Day 31Population: The safety analysis set was defined as all participants who received at least one dose of study drug.
Outcome measures
| Measure |
Japanese Cohort 1: Placebo
n=4 Participants
TAK-831 matching placebo, tablets, orally, once on Day 1 of Part 1 and Day 1 (Day 9) of Part 2 in healthy Japanese participants.
|
Japanese Cohort 1: TAK-831 100 mg
n=6 Participants
TAK-831 100 mg, tablet, orally, once on Day 1 of Part 1 in healthy Japanese participants.
|
Japanese Cohort 1: TAK-831 300 mg
n=6 Participants
TAK-831 300 mg, tablet, orally, once on Day 1 (Day 9) of Part 2 in healthy Japanese participants.
|
Japanese Cohort 2, 4 and 5: Pooled Placebo
n=6 Participants
TAK-831 matching placebo, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
|
Japanese Cohort 2: TAK-831 300 mg
n=6 Participants
TAK-831 300 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
|
Japanese Cohort 4: TAK-831 600 mg
n=6 Participants
TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
|
Japanese Cohort 5: TAK-831 50 mg
n=6 Participants
TAK-831 50 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
|
Chinese Cohort 3: Placebo
n=6 Participants
TAK-831 matching placebo, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Chinese participants.
|
Chinese Cohort 3: TAK-831 600 mg
n=2 Participants
TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Chinese participants.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting at Least One TEAE Related to Laboratory Test Results
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Cohort 1: Baseline up to Day 23; Cohorts 2-5: Baseline up to Day 31Population: The safety analysis set was defined as all participants who received at least one dose of study drug.
Outcome measures
| Measure |
Japanese Cohort 1: Placebo
n=4 Participants
TAK-831 matching placebo, tablets, orally, once on Day 1 of Part 1 and Day 1 (Day 9) of Part 2 in healthy Japanese participants.
|
Japanese Cohort 1: TAK-831 100 mg
n=6 Participants
TAK-831 100 mg, tablet, orally, once on Day 1 of Part 1 in healthy Japanese participants.
|
Japanese Cohort 1: TAK-831 300 mg
n=6 Participants
TAK-831 300 mg, tablet, orally, once on Day 1 (Day 9) of Part 2 in healthy Japanese participants.
|
Japanese Cohort 2, 4 and 5: Pooled Placebo
n=6 Participants
TAK-831 matching placebo, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
|
Japanese Cohort 2: TAK-831 300 mg
n=6 Participants
TAK-831 300 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
|
Japanese Cohort 4: TAK-831 600 mg
n=6 Participants
TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
|
Japanese Cohort 5: TAK-831 50 mg
n=6 Participants
TAK-831 50 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
|
Chinese Cohort 3: Placebo
n=2 Participants
TAK-831 matching placebo, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Chinese participants.
|
Chinese Cohort 3: TAK-831 600 mg
n=6 Participants
TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Chinese participants.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting at Least One TEAE Related to Vital Sign
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Cohort 1: Baseline up to Day 23; Cohorts 2-5: Baseline up to Day 31Population: The safety analysis set was defined as all participants who received at least one dose of study drug.
Outcome measures
| Measure |
Japanese Cohort 1: Placebo
n=4 Participants
TAK-831 matching placebo, tablets, orally, once on Day 1 of Part 1 and Day 1 (Day 9) of Part 2 in healthy Japanese participants.
|
Japanese Cohort 1: TAK-831 100 mg
n=6 Participants
TAK-831 100 mg, tablet, orally, once on Day 1 of Part 1 in healthy Japanese participants.
|
Japanese Cohort 1: TAK-831 300 mg
n=6 Participants
TAK-831 300 mg, tablet, orally, once on Day 1 (Day 9) of Part 2 in healthy Japanese participants.
|
Japanese Cohort 2, 4 and 5: Pooled Placebo
n=6 Participants
TAK-831 matching placebo, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
|
Japanese Cohort 2: TAK-831 300 mg
n=6 Participants
TAK-831 300 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
|
Japanese Cohort 4: TAK-831 600 mg
n=6 Participants
TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
|
Japanese Cohort 5: TAK-831 50 mg
n=6 Participants
TAK-831 50 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
|
Chinese Cohort 3: Placebo
n=2 Participants
TAK-831 matching placebo, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Chinese participants.
|
Chinese Cohort 3: TAK-831 600 mg
n=6 Participants
TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Chinese participants.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting at Least One TEAE Related to Body Weight
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Cohort 1: Baseline up to Day 23; Cohorts 2-5: Baseline up to Day 31Population: The safety analysis set was defined as all participants who received at least one dose of study drug.
Outcome measures
| Measure |
Japanese Cohort 1: Placebo
n=4 Participants
TAK-831 matching placebo, tablets, orally, once on Day 1 of Part 1 and Day 1 (Day 9) of Part 2 in healthy Japanese participants.
|
Japanese Cohort 1: TAK-831 100 mg
n=6 Participants
TAK-831 100 mg, tablet, orally, once on Day 1 of Part 1 in healthy Japanese participants.
|
Japanese Cohort 1: TAK-831 300 mg
n=6 Participants
TAK-831 300 mg, tablet, orally, once on Day 1 (Day 9) of Part 2 in healthy Japanese participants.
|
Japanese Cohort 2, 4 and 5: Pooled Placebo
n=6 Participants
TAK-831 matching placebo, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
|
Japanese Cohort 2: TAK-831 300 mg
n=6 Participants
TAK-831 300 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
|
Japanese Cohort 4: TAK-831 600 mg
n=6 Participants
TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
|
Japanese Cohort 5: TAK-831 50 mg
n=6 Participants
TAK-831 50 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
|
Chinese Cohort 3: Placebo
n=2 Participants
TAK-831 matching placebo, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Chinese participants.
|
Chinese Cohort 3: TAK-831 600 mg
n=6 Participants
TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Chinese participants.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting at Least One TEAE Related to 12-lead Electrocardiogram (ECG) Parameters
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Cohort 1: Day 1 pre-dose and at 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48 and 72 hours post-dose; Cohorts 2 to 5: Day 1 pre-dose and at 0.25, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48 and 72 hours post-dosePopulation: The pharmacokinetic (PK) analysis set included participants who received at least one dose of study drug, and who were appropriately evaluable for at least 1 PK parameter.
Outcome measures
| Measure |
Japanese Cohort 1: Placebo
n=6 Participants
TAK-831 matching placebo, tablets, orally, once on Day 1 of Part 1 and Day 1 (Day 9) of Part 2 in healthy Japanese participants.
|
Japanese Cohort 1: TAK-831 100 mg
n=6 Participants
TAK-831 100 mg, tablet, orally, once on Day 1 of Part 1 in healthy Japanese participants.
|
Japanese Cohort 1: TAK-831 300 mg
n=6 Participants
TAK-831 300 mg, tablet, orally, once on Day 1 (Day 9) of Part 2 in healthy Japanese participants.
|
Japanese Cohort 2, 4 and 5: Pooled Placebo
n=6 Participants
TAK-831 matching placebo, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
|
Japanese Cohort 2: TAK-831 300 mg
n=6 Participants
TAK-831 300 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
|
Japanese Cohort 4: TAK-831 600 mg
n=6 Participants
TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
|
Japanese Cohort 5: TAK-831 50 mg
TAK-831 50 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
|
Chinese Cohort 3: Placebo
TAK-831 matching placebo, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Chinese participants.
|
Chinese Cohort 3: TAK-831 600 mg
TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Chinese participants.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration for TAK-831
|
985.5 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 20.8
|
1823 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 53.7
|
981.7 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 29.1
|
1602 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 42.1
|
339.9 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 33.3
|
1807 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 28.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 17 pre-dose and at 0.25, 0.5, 1, 1.5, 2, 4, 8, 12 and 24 hours post-dosePopulation: The PK analysis set included participants who received at least one dose of study drug, and who were appropriately evaluable for at least 1 PK parameter.
Outcome measures
| Measure |
Japanese Cohort 1: Placebo
n=6 Participants
TAK-831 matching placebo, tablets, orally, once on Day 1 of Part 1 and Day 1 (Day 9) of Part 2 in healthy Japanese participants.
|
Japanese Cohort 1: TAK-831 100 mg
n=6 Participants
TAK-831 100 mg, tablet, orally, once on Day 1 of Part 1 in healthy Japanese participants.
|
Japanese Cohort 1: TAK-831 300 mg
n=6 Participants
TAK-831 300 mg, tablet, orally, once on Day 1 (Day 9) of Part 2 in healthy Japanese participants.
|
Japanese Cohort 2, 4 and 5: Pooled Placebo
n=6 Participants
TAK-831 matching placebo, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
|
Japanese Cohort 2: TAK-831 300 mg
TAK-831 300 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
|
Japanese Cohort 4: TAK-831 600 mg
TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
|
Japanese Cohort 5: TAK-831 50 mg
TAK-831 50 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
|
Chinese Cohort 3: Placebo
TAK-831 matching placebo, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Chinese participants.
|
Chinese Cohort 3: TAK-831 600 mg
TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Chinese participants.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohorts 2 to 5, Cmax, ss: Maximum Observed Steady-state Plasma Concentration During a Dosing Interval for TAK-831
|
831.8 ng/mL
Geometric Coefficient of Variation 29.1
|
1903 ng/mL
Geometric Coefficient of Variation 33.6
|
417.0 ng/mL
Geometric Coefficient of Variation 23.8
|
1581 ng/mL
Geometric Coefficient of Variation 42.4
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohort 1: Day 1 pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72 hours post-dose; Cohorts 2 to 5: Day 1 pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72 hours post-dose; Day 17 pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 8, 12, 24 hours post-dosePopulation: The PK analysis set included participants who received at least one dose of study drug, and who were appropriately evaluable for at least 1 PK parameter.
Outcome measures
| Measure |
Japanese Cohort 1: Placebo
n=6 Participants
TAK-831 matching placebo, tablets, orally, once on Day 1 of Part 1 and Day 1 (Day 9) of Part 2 in healthy Japanese participants.
|
Japanese Cohort 1: TAK-831 100 mg
n=6 Participants
TAK-831 100 mg, tablet, orally, once on Day 1 of Part 1 in healthy Japanese participants.
|
Japanese Cohort 1: TAK-831 300 mg
n=6 Participants
TAK-831 300 mg, tablet, orally, once on Day 1 (Day 9) of Part 2 in healthy Japanese participants.
|
Japanese Cohort 2, 4 and 5: Pooled Placebo
n=6 Participants
TAK-831 matching placebo, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
|
Japanese Cohort 2: TAK-831 300 mg
n=6 Participants
TAK-831 300 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
|
Japanese Cohort 4: TAK-831 600 mg
n=6 Participants
TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
|
Japanese Cohort 5: TAK-831 50 mg
TAK-831 50 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
|
Chinese Cohort 3: Placebo
TAK-831 matching placebo, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Chinese participants.
|
Chinese Cohort 3: TAK-831 600 mg
TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Chinese participants.
|
|---|---|---|---|---|---|---|---|---|---|
|
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-831
Day 1
|
0.5000 hour
Interval 0.5 to 0.5
|
0.5000 hour
Interval 0.5 to 1.0
|
2.000 hour
Interval 1.5 to 4.0
|
1.750 hour
Interval 1.5 to 4.0
|
0.5000 hour
Interval 0.5 to 1.5
|
1.500 hour
Interval 1.5 to 2.0
|
—
|
—
|
—
|
|
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-831
Day 17
|
NA hour
Tmax for Cohort 1 was not planned to analyzed on Day 17.
|
NA hour
Tmax for Cohort 1 was not planned to analyzed on Day 17.
|
1.750 hour
Interval 1.0 to 4.0
|
2.000 hour
Interval 1.0 to 4.0
|
0.5000 hour
Interval 0.5 to 2.0
|
2.000 hour
Interval 1.5 to 2.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohort 1: Day 1 pre-dose and at 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48 and 72 hours post-dose; Cohorts 2 to 5: Day 1 pre-dose and at 0.25, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48 and 72 hours post-dosePopulation: The PK analysis set included participants who received at least one dose of study drug, and who were appropriately evaluable for at least 1 PK parameter.
Outcome measures
| Measure |
Japanese Cohort 1: Placebo
n=6 Participants
TAK-831 matching placebo, tablets, orally, once on Day 1 of Part 1 and Day 1 (Day 9) of Part 2 in healthy Japanese participants.
|
Japanese Cohort 1: TAK-831 100 mg
n=6 Participants
TAK-831 100 mg, tablet, orally, once on Day 1 of Part 1 in healthy Japanese participants.
|
Japanese Cohort 1: TAK-831 300 mg
n=6 Participants
TAK-831 300 mg, tablet, orally, once on Day 1 (Day 9) of Part 2 in healthy Japanese participants.
|
Japanese Cohort 2, 4 and 5: Pooled Placebo
n=6 Participants
TAK-831 matching placebo, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
|
Japanese Cohort 2: TAK-831 300 mg
n=6 Participants
TAK-831 300 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
|
Japanese Cohort 4: TAK-831 600 mg
n=6 Participants
TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
|
Japanese Cohort 5: TAK-831 50 mg
TAK-831 50 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
|
Chinese Cohort 3: Placebo
TAK-831 matching placebo, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Chinese participants.
|
Chinese Cohort 3: TAK-831 600 mg
TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Chinese participants.
|
|---|---|---|---|---|---|---|---|---|---|
|
AUClast: Area Under the Plasma Concentration-time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration for TAK-831
|
1553 hour*nanogram per milliliter(h*ng/mL)
Geometric Coefficient of Variation 11.8
|
3630 hour*nanogram per milliliter(h*ng/mL)
Geometric Coefficient of Variation 11.9
|
3700 hour*nanogram per milliliter(h*ng/mL)
Geometric Coefficient of Variation 32.2
|
6477 hour*nanogram per milliliter(h*ng/mL)
Geometric Coefficient of Variation 26.2
|
847.4 hour*nanogram per milliliter(h*ng/mL)
Geometric Coefficient of Variation 21.5
|
5504 hour*nanogram per milliliter(h*ng/mL)
Geometric Coefficient of Variation 22.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohort 1: Day 1 pre-dose and at 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48 and 72 hours post-dose; Cohorts 2 to 5: Day 1 pre-dose and at 0.25, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48 and 72 hours post-dosePopulation: The PK analysis set included participants who received at least one dose of study drug, and who were appropriately evaluable for at least 1 PK parameter.
Outcome measures
| Measure |
Japanese Cohort 1: Placebo
n=6 Participants
TAK-831 matching placebo, tablets, orally, once on Day 1 of Part 1 and Day 1 (Day 9) of Part 2 in healthy Japanese participants.
|
Japanese Cohort 1: TAK-831 100 mg
n=6 Participants
TAK-831 100 mg, tablet, orally, once on Day 1 of Part 1 in healthy Japanese participants.
|
Japanese Cohort 1: TAK-831 300 mg
n=6 Participants
TAK-831 300 mg, tablet, orally, once on Day 1 (Day 9) of Part 2 in healthy Japanese participants.
|
Japanese Cohort 2, 4 and 5: Pooled Placebo
n=6 Participants
TAK-831 matching placebo, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
|
Japanese Cohort 2: TAK-831 300 mg
n=6 Participants
TAK-831 300 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
|
Japanese Cohort 4: TAK-831 600 mg
n=6 Participants
TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
|
Japanese Cohort 5: TAK-831 50 mg
TAK-831 50 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
|
Chinese Cohort 3: Placebo
TAK-831 matching placebo, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Chinese participants.
|
Chinese Cohort 3: TAK-831 600 mg
TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Chinese participants.
|
|---|---|---|---|---|---|---|---|---|---|
|
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-831
|
1581 h*ng/mL
Geometric Coefficient of Variation 11.7
|
3653 h*ng/mL
Geometric Coefficient of Variation 12.2
|
3730 h*ng/mL
Geometric Coefficient of Variation 31.9
|
6518 h*ng/mL
Geometric Coefficient of Variation 26.2
|
923.6 h*ng/mL
Geometric Coefficient of Variation 22.1
|
5530 h*ng/mL
Geometric Coefficient of Variation 22.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: pre-dose and at 0.25, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48 and 72 hours post-dose and Day 17: pre-dose and at 0.25, 0.5, 1, 1.5, 2, 4, 8, 12, and 24 hours post-dosePopulation: The PK analysis set included participants who received at least one dose of study drug, and who were appropriately evaluable for at least 1 PK parameter.
Outcome measures
| Measure |
Japanese Cohort 1: Placebo
n=6 Participants
TAK-831 matching placebo, tablets, orally, once on Day 1 of Part 1 and Day 1 (Day 9) of Part 2 in healthy Japanese participants.
|
Japanese Cohort 1: TAK-831 100 mg
n=6 Participants
TAK-831 100 mg, tablet, orally, once on Day 1 of Part 1 in healthy Japanese participants.
|
Japanese Cohort 1: TAK-831 300 mg
n=6 Participants
TAK-831 300 mg, tablet, orally, once on Day 1 (Day 9) of Part 2 in healthy Japanese participants.
|
Japanese Cohort 2, 4 and 5: Pooled Placebo
n=6 Participants
TAK-831 matching placebo, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
|
Japanese Cohort 2: TAK-831 300 mg
TAK-831 300 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
|
Japanese Cohort 4: TAK-831 600 mg
TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
|
Japanese Cohort 5: TAK-831 50 mg
TAK-831 50 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
|
Chinese Cohort 3: Placebo
TAK-831 matching placebo, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Chinese participants.
|
Chinese Cohort 3: TAK-831 600 mg
TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Chinese participants.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohorts 2 to 5, AUCtau: Area Under the Plasma Concentration-time Curve From Time 0 to [Time] Over the Dosing Interval for TAK-831
Day 1
|
3576 h*ng/mL
Geometric Coefficient of Variation 30.6
|
6211 h*ng/mL
Geometric Coefficient of Variation 26.8
|
794.5 h*ng/mL
Geometric Coefficient of Variation 22.2
|
5340 h*ng/mL
Geometric Coefficient of Variation 22.3
|
—
|
—
|
—
|
—
|
—
|
|
Cohorts 2 to 5, AUCtau: Area Under the Plasma Concentration-time Curve From Time 0 to [Time] Over the Dosing Interval for TAK-831
Day 17
|
2738 h*ng/mL
Geometric Coefficient of Variation 31.1
|
8237 h*ng/mL
Geometric Coefficient of Variation 28.4
|
983.0 h*ng/mL
Geometric Coefficient of Variation 22.3
|
5839 h*ng/mL
Geometric Coefficient of Variation 21.6
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Japanese Cohort 1: Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Japanese Cohort 1: TAK-831 100 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Japanese Cohort 1: TAK-831 300 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Japanese Cohort 2, 4 and 5: Pooled Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Japanese Cohort 2: TAK-831 300 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Japanese Cohort 4: TAK-831 600 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Japanese Cohort 5: TAK-831 50 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Chinese Cohort 3: Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Chinese Cohort 3: TAK-831 600 mg
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 |
Japanese Cohort 1: Placebo
n=4 participants at risk
TAK-831 matching placebo, tablets, orally, once on Day 1 of Part 1 and Day 1 (Day 9) of Part 2 in healthy Japanese participants.
|
Japanese Cohort 1: TAK-831 100 mg
n=6 participants at risk
TAK-831 100 mg, tablet, orally, once on Day 1 of Part 1 in healthy Japanese participants.
|
Japanese Cohort 1: TAK-831 300 mg
n=6 participants at risk
TAK-831 300 mg, tablet, orally, once on Day 1 (Day 9) of Part 2 in healthy Japanese participants.
|
Japanese Cohort 2, 4 and 5: Pooled Placebo
n=6 participants at risk
TAK-831 matching placebo, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
|
Japanese Cohort 2: TAK-831 300 mg
n=6 participants at risk
TAK-831 300 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
|
Japanese Cohort 4: TAK-831 600 mg
n=6 participants at risk
TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
|
Japanese Cohort 5: TAK-831 50 mg
n=6 participants at risk
TAK-831 50 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
|
Chinese Cohort 3: Placebo
n=2 participants at risk
TAK-831 matching placebo, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Chinese participants.
|
Chinese Cohort 3: TAK-831 600 mg
n=6 participants at risk
TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Chinese participants.
|
|---|---|---|---|---|---|---|---|---|---|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
|
Investigations
Protein urine present
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
|
Injury, poisoning and procedural complications
Post lumbar puncture syndrome
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
33.3%
2/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
|
Injury, poisoning and procedural complications
Procedural headache
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
|
Injury, poisoning and procedural complications
Vascular procedure complication
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
33.3%
2/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
|
Investigations
Blood pressure systolic increased
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
|
Investigations
Red blood cells urine positive
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
|
Investigations
White blood cells urine positive
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
|
Vascular disorders
Hot flush
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
|
Investigations
Blood urine present
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
50.0%
1/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Generally, the PI may publish results of the study following the publication of results by the Sponsor.
- Publication restrictions are in place
Restriction type: OTHER