NCT03237156

Phase 1 TAK-906 Single and Multiple Ascending Dose Study in Japanese Healthy Male Participants

A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-906 in Japanese Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Takeda · Industry
• Sex: Male
• Age: 20 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple oral doses of TAK-906 in Japanese healthy male participants.

Detailed description

The drug being tested in this study is called TAK-906. TAK-906 is being tested in healthy participants in order to evaluate safety and tolerability of single and multiple oral doses of TAK-906 in Japanese healthy male participants. The study will enroll approximately 24 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups in Cohort 1 or Cohort 3. Study drug will be administered in a double-blind manner which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need), orally, once daily on Day 1 as Single Dose Period and twice daily from Day 3 to 7 as Multiple Dose Period: * TAK-906 50 mg (Cohort 1) * TAK-906 100 mg (Cohort 2) * TAK-906 10 mg (Cohort 3) * Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient Cohort 2 will be conducted after the completion of Cohort 1. This will be conducted in Japan.

Conditions

• Japanese Healthy Adult Male Participants

Interventions

Type	Name	Description
DRUG	TAK-906	TAK-906 capsules.
DRUG	TAK-906 Placebo	Placebo capsules.

Timeline

• Start date: 2017-08-07
• Primary completion: 2017-10-07
• Completion: 2017-10-07
• First posted: 2017-08-02
• Last updated: 2021-01-12
• Results posted: 2019-02-18

Locations

1 site across 1 country: Japan

Regulatory

• FDA-regulated drug study