NCT04461483

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

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).

Detailed 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.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	TAK-935	TAK-935 Tablets
DRUG	Placebo	TAK-935 placebo-matching tablets

Timeline

• Start date: 2020-08-13
• Primary completion: 2020-11-14
• Completion: 2020-11-14
• First posted: 2020-07-08
• Last updated: 2022-01-11
• Results posted: 2022-01-11

Locations

1 site across 1 country: Japan