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A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Dose and Multiple Doses With Titration of TAK-935 in Healthy Japanese Participants

Healthy Volunteer Clinical Trial

Official title:
A Randomized, Double-blind, Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Dose and Multiple Doses With Titration of TAK-935 in Healthy Japanese Subjects

Clinical Trial Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TAK-935 with single ascending doses (Part 1) and multiple doses with titration (Part 2).

Clinical Trial Description

The drug being tested in this study is called TAK-935 tablet. TAK-935 tablet is being tested in Japanese healthy adult men. This study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TAK-935 with single ascending doses (Part 1) and multiple doses with titration (Part 2). The study will enroll up to 33 participants in total (Part 1 + 2). In Part 1, participants will be randomly assigned (by chance, like flipping a coin) to one of these treatment cohorts/groups; - Cohort 1: Single dose of TAK-935 at 200 mg or placebo (fasted) - Cohort 2: Single dose of TAK-935 at 600 mg or placebo (fasted) - Cohort 3: Single dose of TAK-935 at 1200 mg or placebo (fasted) In Part 2, participants will be randomly assigned to one of these treatment groups; - Cohort 4: Multiple doses with titration of TAK-935 or placebo at 100 mg twice daily (BID) from Day 1 to Day 7, 200 mg BID from Day 8 to Day 14 and 300 mg BID from Day 15 to Day 21 (fasted). This single-center trial will be conducted in Japan. The overall time to participate in this study is approximately 36 days for Part 1 and 63 days for Part 2. Participants will be hospitalized for 5 days in Part 1 and 26 days in Part 2. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04461483
Study type Interventional
Source Takeda
Contact
Status Completed
Phase Phase 1
Start date August 13, 2020
Completion date November 14, 2020
View Details
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