Trial Outcomes & Findings for TAK-114 Single- and Multiple-Dose Phase 1 Study (NCT NCT02286518)

NCT ID: NCT02286518

Last Updated: 2016-07-25

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

82 participants

Primary outcome timeframe

Baseline up to 3 days after the last dose of study drug (Day 3 in Part 1), (Day 20 in Part 2) and 7 days after the last dose of study drug (Day 17 in Part 3)

Results posted on

2016-07-25

Participant Flow

Participants took part in the study at 1 investigative site in Japan from 17 Nov 2014 to 29 April 2015.

Healthy Japanese, Caucasian participants enrolled in study with 3 parts to receive TAK-114 single rising dose (SRD) (10 milligram \[mg\], 20 mg and 50 mg, once daily) in Part 1, TAK-114 20 mg in fasted and fed conditions, cross-over in Period 1 and 2 of food effect Part 2 and TAK-114 multiple rising dose (MRD) (20 mg, 50 mg twice daily) in Part 3.

Participant milestones

Participant milestones
Measure	Part 1 SRD-Cohort 1A - 3A: Placebo TAK-114 placebo-matching capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.	Part 1 SRD-Cohort 1A: TAK-114 10 mg TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.	Part 1 SRD-Cohort 2A: TAK-114 20 mg TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.	Part 1 SRD-Cohort 3A: TAK-114 50 mg TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.	Part 1 SRD - Cohort 1B : TAK-114 10 mg TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.	Part 1 SRD-Cohort 2B: TAK-114 20 mg TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.	Part 1 SRD-Cohort 3B: TAK-114 50 mg TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.	Part 2- Cohort 4: TAK-114 Fasted + TAK-114Fed TAK-114 20 mg, capsule, orally, in fasted condition, once on Day 1 of Period 1 (3 days), followed by 14 days washout period, followed by TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of Period 2 (3 days), in Japanese participants.	Part 2 Cohort 4: TAK-114 Fed + TAK-114 Fasted TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of Period 2 (3 days), followed by 14 days washout period, followed by TAK-114 20 mg, capsule, orally, in fasted condition, once on Day 1 of Period 2 (3 days), in Japanese participants.	Part 3 Placebo Cohort 5A - 6A: Placebo TAK-114 placebo-matching, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.	Part 3 Cohort 5A MRD: TAK-114 20 mg TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.	Part 3 Cohort 6A MRD: TAK-114 50 mg TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.	Part 3 Cohort 5B MRD: TAK-114 20 mg TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.	Part 3 Cohort 6B MRD: TAK-114 50 mg TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
All Parts (16 Days) STARTED	6	6	6	6	6	6	6	6	6	4	6	6	6	6
All Parts (16 Days) COMPLETED	6	6	6	6	6	6	6	6	6	4	6	6	6	6
All Parts (16 Days) NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Washout Crossover Period(Part 2:14 Days) STARTED	0	0	0	0	0	0	0	6	6	0	0	0	0	0
Washout Crossover Period(Part 2:14 Days) COMPLETED	0	0	0	0	0	0	0	6	6	0	0	0	0	0
Washout Crossover Period(Part 2:14 Days) NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Crossover Treatment (Part 2: 3 Days) STARTED	0	0	0	0	0	0	0	6	6	0	0	0	0	0
Crossover Treatment (Part 2: 3 Days) COMPLETED	0	0	0	0	0	0	0	6	6	0	0	0	0	0
Crossover Treatment (Part 2: 3 Days) NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

TAK-114 Single- and Multiple-Dose Phase 1 Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1 SRD-Cohort 1A - 3A: Placebo n=6 Participants TAK-114 placebo-matching capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.	Part 1 SRD-Cohort 1A: TAK-114 10 mg n=6 Participants TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.	Part 1 SRD-Cohort 2A: TAK-114 20 mg n=6 Participants TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.	Part 1 SRD-Cohort 3A: TAK-114 50 mg n=6 Participants TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.	Part 1 SRD - Cohort 1B : TAK-114 10 mg n=6 Participants TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.	Part 1 SRD-Cohort 2B: TAK-114 20 mg n=6 Participants TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.	Part 1 SRD-Cohort 3B: TAK-114 50 mg n=6 Participants TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.	Part 2- Cohort 4: TAK-114 Fasted + TAK-114Fed n=6 Participants TAK-114 20 mg, capsule, orally, in fasted condition, once on Day 1 of Period 1 (3 days), followed by 14 days washout period, followed by TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of Period 2 (3 days), in Japanese participants.	Part 2 Cohort 4: TAK-114 20 mg Fed + TAK-114 20 mg Fasted n=6 Participants TAK-114 20 mg, capsule, orally, once on Day 1, fed state in period 2 (3 days), followed by a 14 day washout period, further followed by TAK-114 20 mg, capsule, orally, once on Day 1 in fasted state in period 1, in healthy Japanese participants.	Part 3 Placebo Cohort 5A - 6A: Placebo n=4 Participants TAK-114 placebo-matching, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.	Part 3 Cohort 5A MRD: TAK-114 20 mg n=6 Participants TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.	Part 3 Cohort 6A MRD: TAK-114 50 mg n=6 Participants TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.	Part 3 Cohort 5B MRD: TAK-114 20 mg n=6 Participants TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.	Part 3 Cohort 6B MRD: TAK-114 50 mg n=6 Participants TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.	Total n=82 Participants Total of all reporting groups
Age, Continuous Age	31.5 Years STANDARD_DEVIATION 8.48 • n=5 Participants	29.8 Years STANDARD_DEVIATION 7.25 • n=7 Participants	28.3 Years STANDARD_DEVIATION 10.27 • n=5 Participants	34.2 Years STANDARD_DEVIATION 10.26 • n=4 Participants	32.0 Years STANDARD_DEVIATION 7.24 • n=21 Participants	30.3 Years STANDARD_DEVIATION 5.65 • n=10 Participants	26.3 Years STANDARD_DEVIATION 4.97 • n=115 Participants	25.5 Years STANDARD_DEVIATION 3.51 • n=6 Participants	35.3 Years STANDARD_DEVIATION 8.12 • n=6 Participants	41.0 Years STANDARD_DEVIATION 4.08 • n=64 Participants	30.3 Years STANDARD_DEVIATION 9.22 • n=17 Participants	33.7 Years STANDARD_DEVIATION 10.73 • n=21 Participants	29.3 Years STANDARD_DEVIATION 5.54 • n=22 Participants	33.2 Years STANDARD_DEVIATION 5.74 • n=8 Participants	31.3 Years STANDARD_DEVIATION 7.87 • n=16 Participants
Sex/Gender, Customized Male	6 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	6 Participants n=21 Participants	6 Participants n=10 Participants	6 Participants n=115 Participants	6 Participants n=6 Participants	6 Participants n=6 Participants	4 Participants n=64 Participants	6 Participants n=17 Participants	6 Participants n=21 Participants	6 Participants n=22 Participants	6 Participants n=8 Participants	82 Participants n=16 Participants
Alcohol Classification Drinks Every Day	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	1 Participants n=17 Participants	0 Participants n=21 Participants	1 Participants n=22 Participants	0 Participants n=8 Participants	7 Participants n=16 Participants
Alcohol Classification Drinks a Few Days per Week	2 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	5 Participants n=10 Participants	4 Participants n=115 Participants	1 Participants n=6 Participants	5 Participants n=6 Participants	1 Participants n=64 Participants	2 Participants n=17 Participants	3 Participants n=21 Participants	5 Participants n=22 Participants	4 Participants n=8 Participants	44 Participants n=16 Participants
Alcohol Classification Drinks a Few Days per Month	2 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	0 Participants n=115 Participants	3 Participants n=6 Participants	1 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	1 Participants n=21 Participants	0 Participants n=22 Participants	1 Participants n=8 Participants	12 Participants n=16 Participants
Alcohol Classification Does not drink	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	2 Participants n=115 Participants	2 Participants n=6 Participants	0 Participants n=6 Participants	3 Participants n=64 Participants	3 Participants n=17 Participants	2 Participants n=21 Participants	0 Participants n=22 Participants	1 Participants n=8 Participants	19 Participants n=16 Participants
Caffeine Classification Caffeine Consumption	4 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants	4 Participants n=21 Participants	6 Participants n=10 Participants	4 Participants n=115 Participants	5 Participants n=6 Participants	5 Participants n=6 Participants	2 Participants n=64 Participants	4 Participants n=17 Participants	4 Participants n=21 Participants	5 Participants n=22 Participants	6 Participants n=8 Participants	64 Participants n=16 Participants
Caffeine Classification No Caffeine Consumption	2 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	0 Participants n=10 Participants	2 Participants n=115 Participants	1 Participants n=6 Participants	1 Participants n=6 Participants	2 Participants n=64 Participants	2 Participants n=17 Participants	2 Participants n=21 Participants	1 Participants n=22 Participants	0 Participants n=8 Participants	18 Participants n=16 Participants
Smoking Classification Never smoked	4 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	5 Participants n=21 Participants	5 Participants n=10 Participants	3 Participants n=115 Participants	3 Participants n=6 Participants	4 Participants n=6 Participants	1 Participants n=64 Participants	3 Participants n=17 Participants	5 Participants n=21 Participants	4 Participants n=22 Participants	4 Participants n=8 Participants	52 Participants n=16 Participants
Smoking Classification Ex-smoker	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=10 Participants	3 Participants n=115 Participants	3 Participants n=6 Participants	2 Participants n=6 Participants	3 Participants n=64 Participants	3 Participants n=17 Participants	1 Participants n=21 Participants	2 Participants n=22 Participants	2 Participants n=8 Participants	30 Participants n=16 Participants

PRIMARY outcome

Timeframe: Baseline up to 3 days after the last dose of study drug (Day 3 in Part 1), (Day 20 in Part 2) and 7 days after the last dose of study drug (Day 17 in Part 3)

Population: The safety analysis set includes all participants who received the study drug.

Outcome measures

Outcome measures
Measure	Part 2 Cohort 4: TAK-114 20 mg Fed n=12 Participants TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.	Part 1 SRD-Cohort 1A - 3A: Placebo n=6 Participants TAK-114 placebo-matching capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.	Part 1 SRD-Cohort 1A: TAK-114 10 mg n=6 Participants TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.	Part 1 SRD-Cohort 2A: TAK-114 20 mg n=6 Participants TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.	Part 1 SRD-Cohort 3A: TAK-114 50 mg n=6 Participants TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.	Part 1 SRD - Cohort 1B : TAK-114 10 mg n=6 Participants TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.	Part 1 SRD-Cohort 2B: TAK-114 20 mg n=6 Participants TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.	Part 1 SRD-Cohort 3B: TAK-114 50 mg n=6 Participants TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.	Part 2 Cohort 4: TAK-114 20 mg Fed n=12 Participants TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.	Part 3 Placebo Cohort 5A - 6A: Placebo n=4 Participants TAK-114 placebo-matching, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.	Part 3 Cohort 5A MRD: TAK-114 20 mg n=6 Participants TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.	Part 3 Cohort 6A MRD: TAK-114 50 mg n=6 Participants TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.	Part 3 Cohort 5B MRD: TAK-114 20 mg n=6 Participants TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.	Part 3 Cohort 6B MRD: TAK-114 50 mg n=6 Participants TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)	0 participants	0 participants	0 participants	1 participants	1 participants	1 participants	0 participants	1 participants	1 participants	0 participants	3 participants	5 participants	2 participants	6 participants

PRIMARY outcome

Timeframe: Baseline up to Day 3 in Part 1, Day 20 in Part 2 and Day 17 in Part 3

Population: The safety analysis set includes all participants who received the study drug.

Outcome measures

Outcome measures
Measure	Part 2 Cohort 4: TAK-114 20 mg Fed n=12 Participants TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.	Part 1 SRD-Cohort 1A - 3A: Placebo n=6 Participants TAK-114 placebo-matching capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.	Part 1 SRD-Cohort 1A: TAK-114 10 mg n=6 Participants TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.	Part 1 SRD-Cohort 2A: TAK-114 20 mg n=6 Participants TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.	Part 1 SRD-Cohort 3A: TAK-114 50 mg n=6 Participants TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.	Part 1 SRD - Cohort 1B : TAK-114 10 mg n=6 Participants TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.	Part 1 SRD-Cohort 2B: TAK-114 20 mg n=6 Participants TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.	Part 1 SRD-Cohort 3B: TAK-114 50 mg n=6 Participants TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.	Part 2 Cohort 4: TAK-114 20 mg Fed n=12 Participants TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.	Part 3 Placebo Cohort 5A - 6A: Placebo n=4 Participants TAK-114 placebo-matching, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.	Part 3 Cohort 5A MRD: TAK-114 20 mg n=6 Participants TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.	Part 3 Cohort 6A MRD: TAK-114 50 mg n=6 Participants TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.	Part 3 Cohort 5B MRD: TAK-114 20 mg n=6 Participants TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.	Part 3 Cohort 6B MRD: TAK-114 50 mg n=6 Participants TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
Number of Participants With TEAEs Related to Vital Signs	0 participants	0 participants	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: Baseline up to Day 3 in Part 1, Day 20 in Part 2 and Day 17 in Part 3

Population: The safety analysis set includes all participants who received the study drug.

Outcome measures

Outcome measures
Measure	Part 2 Cohort 4: TAK-114 20 mg Fed n=12 Participants TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.	Part 1 SRD-Cohort 1A - 3A: Placebo n=6 Participants TAK-114 placebo-matching capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.	Part 1 SRD-Cohort 1A: TAK-114 10 mg n=6 Participants TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.	Part 1 SRD-Cohort 2A: TAK-114 20 mg n=6 Participants TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.	Part 1 SRD-Cohort 3A: TAK-114 50 mg n=6 Participants TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.	Part 1 SRD - Cohort 1B : TAK-114 10 mg n=6 Participants TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.	Part 1 SRD-Cohort 2B: TAK-114 20 mg n=6 Participants TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.	Part 1 SRD-Cohort 3B: TAK-114 50 mg n=6 Participants TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.	Part 2 Cohort 4: TAK-114 20 mg Fed n=12 Participants TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.	Part 3 Placebo Cohort 5A - 6A: Placebo n=4 Participants TAK-114 placebo-matching, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.	Part 3 Cohort 5A MRD: TAK-114 20 mg n=6 Participants TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.	Part 3 Cohort 6A MRD: TAK-114 50 mg n=6 Participants TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.	Part 3 Cohort 5B MRD: TAK-114 20 mg n=6 Participants TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.	Part 3 Cohort 6B MRD: TAK-114 50 mg n=6 Participants TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
Number of Participants With TEAEs Related to Body Weight	0 participants	0 participants	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: Baseline up to Day 3 in Part 1, Day 20 in Part 2 and Day 17 in Part 3

Population: The safety analysis set includes all participants who received the study drug.

Number of participants who had ECG shifts from "within normal limit" at baseline to "abnormal, clinically significant" after study drug administration were reported.

Outcome measures

Outcome measures
Measure	Part 2 Cohort 4: TAK-114 20 mg Fed n=12 Participants TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.	Part 1 SRD-Cohort 1A - 3A: Placebo n=6 Participants TAK-114 placebo-matching capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.	Part 1 SRD-Cohort 1A: TAK-114 10 mg n=6 Participants TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.	Part 1 SRD-Cohort 2A: TAK-114 20 mg n=6 Participants TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.	Part 1 SRD-Cohort 3A: TAK-114 50 mg n=6 Participants TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.	Part 1 SRD - Cohort 1B : TAK-114 10 mg n=6 Participants TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.	Part 1 SRD-Cohort 2B: TAK-114 20 mg n=6 Participants TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.	Part 1 SRD-Cohort 3B: TAK-114 50 mg n=6 Participants TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.	Part 2 Cohort 4: TAK-114 20 mg Fed n=12 Participants TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.	Part 3 Placebo Cohort 5A - 6A: Placebo n=4 Participants TAK-114 placebo-matching, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.	Part 3 Cohort 5A MRD: TAK-114 20 mg n=6 Participants TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.	Part 3 Cohort 6A MRD: TAK-114 50 mg n=6 Participants TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.	Part 3 Cohort 5B MRD: TAK-114 20 mg n=6 Participants TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.	Part 3 Cohort 6B MRD: TAK-114 50 mg n=6 Participants TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
Number of Participants With Clinically Meaningful Changes From Baseline in 12-lead Electrocardiograms (ECG)	0 participants	0 participants	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: Baseline up to Day 2 (only for Cohorts 1A, 2A, and 3A) in Part 1

Population: The safety analysis set includes all participants who received the study drug.

Outcome measures

Outcome measures
Measure	Part 2 Cohort 4: TAK-114 20 mg Fed TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.	Part 1 SRD-Cohort 1A - 3A: Placebo n=6 Participants TAK-114 placebo-matching capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.	Part 1 SRD-Cohort 1A: TAK-114 10 mg n=6 Participants TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.	Part 1 SRD-Cohort 2A: TAK-114 20 mg n=6 Participants TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.	Part 1 SRD-Cohort 3A: TAK-114 50 mg n=6 Participants TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.	Part 1 SRD - Cohort 1B : TAK-114 10 mg TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.	Part 1 SRD-Cohort 2B: TAK-114 20 mg TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.	Part 1 SRD-Cohort 3B: TAK-114 50 mg TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.	Part 2 Cohort 4: TAK-114 20 mg Fed TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.	Part 3 Placebo Cohort 5A - 6A: Placebo TAK-114 placebo-matching, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.	Part 3 Cohort 5A MRD: TAK-114 20 mg TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.	Part 3 Cohort 6A MRD: TAK-114 50 mg TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.	Part 3 Cohort 5B MRD: TAK-114 20 mg TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.	Part 3 Cohort 6B MRD: TAK-114 50 mg TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
Number of Participants With Clinically Meaningful Changes From Baseline in 12-lead Electrocardiograms (ECG)	—	0 participants 0	0 participants 0	0 participants 0	0 participants 0	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline up to Day 3 in Part 1, Day 20 in Part 2 and Day 17 in Part 3

Population: The safety analysis set includes all participants who received the study drug.

Outcome measures

Outcome measures
Measure	Part 2 Cohort 4: TAK-114 20 mg Fed n=12 Participants TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.	Part 1 SRD-Cohort 1A - 3A: Placebo n=6 Participants TAK-114 placebo-matching capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.	Part 1 SRD-Cohort 1A: TAK-114 10 mg n=6 Participants TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.	Part 1 SRD-Cohort 2A: TAK-114 20 mg n=6 Participants TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.	Part 1 SRD-Cohort 3A: TAK-114 50 mg n=6 Participants TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.	Part 1 SRD - Cohort 1B : TAK-114 10 mg n=6 Participants TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.	Part 1 SRD-Cohort 2B: TAK-114 20 mg n=6 Participants TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.	Part 1 SRD-Cohort 3B: TAK-114 50 mg n=6 Participants TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.	Part 2 Cohort 4: TAK-114 20 mg Fed n=12 Participants TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.	Part 3 Placebo Cohort 5A - 6A: Placebo n=4 Participants TAK-114 placebo-matching, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.	Part 3 Cohort 5A MRD: TAK-114 20 mg n=6 Participants TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.	Part 3 Cohort 6A MRD: TAK-114 50 mg n=6 Participants TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.	Part 3 Cohort 5B MRD: TAK-114 20 mg n=6 Participants TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.	Part 3 Cohort 6B MRD: TAK-114 50 mg n=6 Participants TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis C-reactive protein increased	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	1 participants	1 participants	1 participants	3 participants
Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis White blood cell count increased	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	1 participants	1 participants	1 participants	0 participants
Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis Alanine aminotransferase increased	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	1 participants	0 participants	0 participants	0 participants
Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis Aspartate aminotransferase increased	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	1 participants	0 participants	0 participants	0 participants
Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis Blood triglycerides increased	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	1 participants	0 participants	0 participants
Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis Haemoglobin decreased	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	1 participants	0 participants	0 participants	0 participants
Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis High density lipoprotein decreased	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	1 participants

SECONDARY outcome

Timeframe: Day1: predose and at multiple time-points (up to 48 hours) postdose for Part 1; Day 1:predose and at multiple time-points (up to 48 hours) postdose in each period for Part 2; Day 10:predose and at multiple time points (up to 12 hours) postdose for Part 3

Population: The Pharmacokinetic (PK) analysis set includes all participants who had received the study drug and met the essential requirements defined in the study protocol without any critical protocol violations, and in whom PK assessment was possible.

Outcome measures

Outcome measures
Measure	Part 2 Cohort 4: TAK-114 20 mg Fed n=12 Participants TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.	Part 1 SRD-Cohort 1A - 3A: Placebo n=6 Participants TAK-114 placebo-matching capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.	Part 1 SRD-Cohort 1A: TAK-114 10 mg n=5 Participants TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.	Part 1 SRD-Cohort 2A: TAK-114 20 mg n=6 Participants TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.	Part 1 SRD-Cohort 3A: TAK-114 50 mg n=6 Participants TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.	Part 1 SRD - Cohort 1B : TAK-114 10 mg n=6 Participants TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.	Part 1 SRD-Cohort 2B: TAK-114 20 mg n=6 Participants TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.	Part 1 SRD-Cohort 3B: TAK-114 50 mg n=12 Participants TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.	Part 2 Cohort 4: TAK-114 20 mg Fed n=6 Participants TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.	Part 3 Placebo Cohort 5A - 6A: Placebo n=5 Participants TAK-114 placebo-matching, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.	Part 3 Cohort 5A MRD: TAK-114 20 mg n=6 Participants TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.	Part 3 Cohort 6A MRD: TAK-114 50 mg n=3 Participants TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.	Part 3 Cohort 5B MRD: TAK-114 20 mg TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.	Part 3 Cohort 6B MRD: TAK-114 50 mg TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
Cmax - Maximum Observed Plasma Concentration for TAK-114	150.8 picogram per milliliter (pg/mL) Standard Deviation 56.655	53.15 picogram per milliliter (pg/mL) Standard Deviation 10.051	68.74 picogram per milliliter (pg/mL) Standard Deviation 26.789	168.1 picogram per milliliter (pg/mL) Standard Deviation 71.210	30.98 picogram per milliliter (pg/mL) Standard Deviation 14.822	74.72 picogram per milliliter (pg/mL) Standard Deviation 17.886	140.8 picogram per milliliter (pg/mL) Standard Deviation 47.499	98.12 picogram per milliliter (pg/mL) Standard Deviation 34.944	39.37 picogram per milliliter (pg/mL) Standard Deviation 4.8430	112.6 picogram per milliliter (pg/mL) Standard Deviation 12.857	24.53 picogram per milliliter (pg/mL) Standard Deviation 7.1949	106.7 picogram per milliliter (pg/mL) Standard Deviation 36.967	—	—

SECONDARY outcome

Timeframe: Day 1: predose and at multiple time-points (up to 48 hours) postdose for Part 1; Day 1: predose and at multiple time-points (up to 48 hours) postdose in each period for Part 2

Outcome measures

Outcome measures
Measure	Part 2 Cohort 4: TAK-114 20 mg Fed n=12 Participants TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.	Part 1 SRD-Cohort 1A - 3A: Placebo n=6 Participants TAK-114 placebo-matching capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.	Part 1 SRD-Cohort 1A: TAK-114 10 mg n=5 Participants TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.	Part 1 SRD-Cohort 2A: TAK-114 20 mg n=6 Participants TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.	Part 1 SRD-Cohort 3A: TAK-114 50 mg n=3 Participants TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.	Part 1 SRD - Cohort 1B : TAK-114 10 mg n=5 Participants TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.	Part 1 SRD-Cohort 2B: TAK-114 20 mg n=6 Participants TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.	Part 1 SRD-Cohort 3B: TAK-114 50 mg n=12 Participants TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.	Part 2 Cohort 4: TAK-114 20 mg Fed TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.	Part 3 Placebo Cohort 5A - 6A: Placebo TAK-114 placebo-matching, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.	Part 3 Cohort 5A MRD: TAK-114 20 mg TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.	Part 3 Cohort 6A MRD: TAK-114 50 mg TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.	Part 3 Cohort 5B MRD: TAK-114 20 mg TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.	Part 3 Cohort 6B MRD: TAK-114 50 mg TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
AUC (0-Infinity) - Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for Unchanged TAK-114: Part 1 and Part 2	918.2 picogramhour per milliliter (pghr/mL) Standard Deviation 197.12	469.2 picogramhour per milliliter (pghr/mL) Standard Deviation 112.44	762.2 picogramhour per milliliter (pghr/mL) Standard Deviation 195.14	1708 picogramhour per milliliter (pghr/mL) Standard Deviation 607.24	472.3 picogramhour per milliliter (pghr/mL) Standard Deviation 77.694	879.2 picogramhour per milliliter (pghr/mL) Standard Deviation 142.15	2180 picogramhour per milliliter (pghr/mL) Standard Deviation 405.22	918.9 picogramhour per milliliter (pghr/mL) Standard Deviation 165.75	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day10: predose and at multiple time points (up to 12 hours) postdose for Part 3

Outcome measures

Outcome measures
Measure	Part 2 Cohort 4: TAK-114 20 mg Fed TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.	Part 1 SRD-Cohort 1A - 3A: Placebo n=6 Participants TAK-114 placebo-matching capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.	Part 1 SRD-Cohort 1A: TAK-114 10 mg n=5 Participants TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.	Part 1 SRD-Cohort 2A: TAK-114 20 mg n=6 Participants TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.	Part 1 SRD-Cohort 3A: TAK-114 50 mg n=3 Participants TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.	Part 1 SRD - Cohort 1B : TAK-114 10 mg TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.	Part 1 SRD-Cohort 2B: TAK-114 20 mg TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.	Part 1 SRD-Cohort 3B: TAK-114 50 mg TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.	Part 2 Cohort 4: TAK-114 20 mg Fed TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.	Part 3 Placebo Cohort 5A - 6A: Placebo TAK-114 placebo-matching, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.	Part 3 Cohort 5A MRD: TAK-114 20 mg TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.	Part 3 Cohort 6A MRD: TAK-114 50 mg TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.	Part 3 Cohort 5B MRD: TAK-114 20 mg TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.	Part 3 Cohort 6B MRD: TAK-114 50 mg TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
AUC (0-tau) - Area Under the Plasma Concentration-Time Curve From Time 0 to Time Tau for TAK-114: Part 3	—	251.3 pg*hr/mL Standard Deviation 47.209	838.0 pg*hr/mL Standard Deviation 140.39	183.2 pg*hr/mL Standard Deviation 49.061	749.7 pg*hr/mL Standard Deviation 243.56	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day1:predose and at multiple time-points (up to 48 hours) postdose for Part 1; Day1:predose and at multiple time-points (up to 48 hours) postdose in each period for Part 2; Day 10: predose and at multiple time points (up to 12 hours) postdose for Part 3

Outcome measures

Outcome measures
Measure	Part 2 Cohort 4: TAK-114 20 mg Fed n=12 Participants TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.	Part 1 SRD-Cohort 1A - 3A: Placebo n=6 Participants TAK-114 placebo-matching capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.	Part 1 SRD-Cohort 1A: TAK-114 10 mg n=5 Participants TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.	Part 1 SRD-Cohort 2A: TAK-114 20 mg n=6 Participants TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.	Part 1 SRD-Cohort 3A: TAK-114 50 mg n=3 Participants TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.	Part 1 SRD - Cohort 1B : TAK-114 10 mg n=5 Participants TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.	Part 1 SRD-Cohort 2B: TAK-114 20 mg n=6 Participants TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.	Part 1 SRD-Cohort 3B: TAK-114 50 mg n=12 Participants TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.	Part 2 Cohort 4: TAK-114 20 mg Fed n=6 Participants TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.	Part 3 Placebo Cohort 5A - 6A: Placebo n=5 Participants TAK-114 placebo-matching, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.	Part 3 Cohort 5A MRD: TAK-114 20 mg n=6 Participants TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.	Part 3 Cohort 6A MRD: TAK-114 50 mg n=3 Participants TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.	Part 3 Cohort 5B MRD: TAK-114 20 mg TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.	Part 3 Cohort 6B MRD: TAK-114 50 mg TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
Mean Terminal Phase Elimination Half-life (T1/2) for TAK-114	3.705 hour Standard Deviation 1.1044	4.108 hour Standard Deviation 0.76763	5.500 hour Standard Deviation 2.7925	5.272 hour Standard Deviation 2.0918	7.417 hour Standard Deviation 1.9012	5.822 hour Standard Deviation 0.75503	6.213 hour Standard Deviation 1.0856	4.294 hour Standard Deviation 1.0600	4.972 hour Standard Deviation 1.6574	6.970 hour Standard Deviation 1.0813	6.045 hour Standard Deviation 2.2456	7.283 hour Standard Deviation 2.2407	—	—

SECONDARY outcome

Timeframe: Days 1 and 10: predose and at multiple time points (up to 12 hours) postdose for Part 3

Mean R(Cmax) was estimated as the ratio of Cmax on Day 10 and Cmax on Day 1. Cmax is the peak plasma drug concentration of TAK-114.

Outcome measures

Outcome measures
Measure	Part 2 Cohort 4: TAK-114 20 mg Fed TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.	Part 1 SRD-Cohort 1A - 3A: Placebo n=6 Participants TAK-114 placebo-matching capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.	Part 1 SRD-Cohort 1A: TAK-114 10 mg n=5 Participants TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.	Part 1 SRD-Cohort 2A: TAK-114 20 mg n=6 Participants TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.	Part 1 SRD-Cohort 3A: TAK-114 50 mg n=3 Participants TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.	Part 1 SRD - Cohort 1B : TAK-114 10 mg TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.	Part 1 SRD-Cohort 2B: TAK-114 20 mg TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.	Part 1 SRD-Cohort 3B: TAK-114 50 mg TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.	Part 2 Cohort 4: TAK-114 20 mg Fed TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.	Part 3 Placebo Cohort 5A - 6A: Placebo TAK-114 placebo-matching, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.	Part 3 Cohort 5A MRD: TAK-114 20 mg TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.	Part 3 Cohort 6A MRD: TAK-114 50 mg TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.	Part 3 Cohort 5B MRD: TAK-114 20 mg TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.	Part 3 Cohort 6B MRD: TAK-114 50 mg TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
Mean R(Cmax): Mean Accumulation Coefficient of Observed Maximum Plasma Concentration for TAK-114: Part 3	—	0.2368 ratio Standard Deviation 0.05638	0.3606 ratio Standard Deviation 0.10037	0.2125 ratio Standard Deviation 0.06181	0.3190 ratio Standard Deviation 0.06630	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Days 1 and 10: predose and at multiple time points (up to 12 hours) postdose for Part 3

Mean R(AUC) was estimated as the ratio of AUC(0-tau) on Day 10 and AUC(0-tau) on Day 1. AUC (0-tau) is the area under the plasma concentration-time curve from time 0 to time tau.

Outcome measures

Outcome measures
Measure	Part 2 Cohort 4: TAK-114 20 mg Fed TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.	Part 1 SRD-Cohort 1A - 3A: Placebo n=6 Participants TAK-114 placebo-matching capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.	Part 1 SRD-Cohort 1A: TAK-114 10 mg n=5 Participants TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.	Part 1 SRD-Cohort 2A: TAK-114 20 mg n=6 Participants TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.	Part 1 SRD-Cohort 3A: TAK-114 50 mg n=3 Participants TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.	Part 1 SRD - Cohort 1B : TAK-114 10 mg TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.	Part 1 SRD-Cohort 2B: TAK-114 20 mg TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.	Part 1 SRD-Cohort 3B: TAK-114 50 mg TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.	Part 2 Cohort 4: TAK-114 20 mg Fed TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.	Part 3 Placebo Cohort 5A - 6A: Placebo TAK-114 placebo-matching, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.	Part 3 Cohort 5A MRD: TAK-114 20 mg TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.	Part 3 Cohort 6A MRD: TAK-114 50 mg TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.	Part 3 Cohort 5B MRD: TAK-114 20 mg TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.	Part 3 Cohort 6B MRD: TAK-114 50 mg TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
Mean R(AUC): Mean of Accumulation Coefficient of Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for TAK-114: Part 3	—	0.3032 ratio Standard Deviation 0.07024	0.4768 ratio Standard Deviation 0.15749	0.3128 ratio Standard Deviation 0.08596	0.4087 ratio Standard Deviation 0.04966	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1: 0 to 48 hours postdose

Urinary excretion ratio (% of dose) of TAK-114 in urine were calculated for each participant. Ratio was calculated from the urine concentrations of each analyte and the volume of urine collected.