Conditions: Clinical Pharmacology
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 82
Healthy volunteers: yes

Brief summary:
The purpose of this study is to evaluate the safety and tolerability of TAK-114 following single and multiple ascending oral doses in healthy Japanese male participants.

Detailed description:
This is a phase 1, randomized, double-blind, placebo-controlled, single and multiple oral dose study in healthy Caucasian and Japanese male participants.

The study is composed of three parts, Single-dose Ascending Part, Food Effect Part and Multiple-dose Ascending Part. Single-dose Ascending Part and Multiple-dose Ascending Part are designed as a randomized, double-blind or open-label, placebo-controlled, sequential-cohort, ascending single or multiple oral dose study of TAK-114 or matched placebo. The Food Effect Part is designed as a randomized, open-label, 2-period crossover study of a single dose of TAK-114.

Arms:
arm 1: Orally, once only. arm 2: Orally, once arm 3: Orally, once arm 4: Orally, once arm 5: Orally, once arm 6: Orally, once arm 7: Period 1: Single-dose administration in a fasting state Period 2: Single-dose administration 30 minutes after breakfast arm 8: Period 1: Single-dose administration 30 minutes after breakfast Period 2: Single-dose administration in a fasting state arm 9: Orally, Twice daily, 10 days arm 10: Orally, Twice daily, 10 days arm 11: Orally, Twice daily, 10 days arm 12: Orally, Twice daily, 10 days arm 13: Cohort 1A, 2A, 3A: Orally, once arm 14: Cohort 5A: Orally, Twice daily, 10 days arm 15: Cohort 6A: Orally, Twice daily, 10 days

Interventions: intervention 1: TAK-114 10 mg capsule intervention 2: TAK-114 matched placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: