A Single- and Multiple-Dose Study of the Pharmacokinetics of TAK-491 in Healthy Chinese Participants

Healthy Volunteer Clinical Trial

Official title: A Randomized, Open-Label and Double-Blind, Placebo-Controlled, Single- and Multiple-Dose, Phase 1 Study of the Pharmacokinetics of TAK-491 40 mg and 80 mg in Healthy Chinese Subjects

Status Completed

Clinical Trial Summary

The purpose of this study is to assess the pharmacokinetics and safety of single- and multiple-dose of TAK-491 in healthy Chinese participants.

Clinical Trial Description

The drug being tested in this study is called TAK-491. TAK-491 is being tested to treat people who have hypertension. This study will look at the pharmacokinetics of TAK-491 in Chinese participants who take TAK-491.

The study will enroll approximately 64 participants.

The first 16 enrolled participants have been randomly assigned (by chance, like flipping a coin) to 1 of the 2 treatment groups:

• TAK-491 40 mg

• TAK-491 80 mg

All participants will be asked to take 1 tablet at the same time on Day 1 and Day 4 to 10 during the study.

The following 48 randomized participants will be randomly assigned (by chance, like flipping a coin) to 1 of the 3 treatment groups:

• TAK-491 40 mg

• TAK-491 80 mg

• TAK-491 placebo

All participants will be asked to take two tablets at the same time on Day 1 and Day 4 to 10 during the study.

This single-center trial will be conducted in China. The overall time to participate in this study is approximately 52 days. Participants will be admitted in the clinic for the first 12 days, and will be contacted by telephone 14 days after last dose of study drug for a follow-up assessment. ;

Related Conditions & MeSH terms

• Healthy Volunteer

• NCT number: NCT02541669
• Study type: Interventional
• Source: Takeda
• Status: Completed
• Phase: Phase 1
• Start date: November 20, 2015
• Completion date: March 17, 2017