Healthy Volunteers Clinical Trial
Official title:
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
The purpose of this study is to evaluate the safety and tolerability of multiple oral doses of TAK-828 in healthy participants.
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.
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