Clinical Pharmacology Clinical Trial
Official title:
A Single-center, Single- and Multiple-Dose Phase 1 Study to Evaluate the Safety and Pharmacokinetics of TAK-114 in Healthy Adult Japanese and Caucasian Male Subjects
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 subjects
This is a phase 1, randomized, double-blind, placebo-controlled, single and multiple oral
dose study in healthy Caucasian and Japanese subjects.
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.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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