NCT02817516

A Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of TAK-828 Escalating Multiple-Doses in Healthy Participants

A Randomized, Double-Blind (Sponsor-Open), Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Escalating Multiple Doses of TAK-828 in Healthy Subjects

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety and tolerability of multiple oral doses of TAK-828 in healthy participants.

Detailed description

The drug being tested in this study is called TAK-828. TAK-828 is being tested to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics in healthy non-Japanese and Japanese participants in Parts 1 and 2, respectively. The study will enroll approximately 56 participants. Participants will be randomly assigned (by chance, like flipping a coin) to receive either TAK-828 or matching placebo. This assignment will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need). Proposed doses: * Part 1: TAK-828 15 mg, 45 mg, 75 mg, 100 mg, and placebo twice daily * Part 2: TAK-828 45 mg, and 100 mg, and placebo twice daily All participants will be asked to take the solution at the same time each day throughout the study. This multi-center trial will be conducted in the United States.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	TAK-828	TAK-828 solution.
DRUG	Placebo	TAK-828 placebo-matching solution.

Timeline

• Start date: 2016-06-30
• Primary completion: 2016-08-22
• Completion: 2016-08-22
• First posted: 2016-06-29
• Last updated: 2019-07-17
• Results posted: 2019-07-17

Locations

1 site across 1 country: United States