NCT02286518

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Takeda · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Clinical Pharmacology

Interventions

Type	Name	Description
DRUG	TAK-114 10 mg capsule
DRUG	TAK-114 matched placebo

Timeline

• Start date: 2014-11-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2014-11-07
• Last updated: 2016-07-25
• Results posted: 2016-07-25

Locations

1 site across 1 country: Japan