Dose Finding Study Clinical Trial
Official title:
A Randomized, Double-Blind (Sponsor-Open), Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Escalating Single Doses of TAK-828 in Healthy Non-Japanese and Japanese Subjects
The purpose of this study is to evaluate the safety and tolerability of single oral doses of TAK-828 in healthy non-Japanese and Japanese participants.
The drug being tested in this study is called TAK-828. TAK-828 is being tested to evaluate
the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single oral
doses of TAK-828 in healthy non-Japanese and Japanese participants.
The study enrolled 36 healthy participants. An interleaving crossover design with placebo
substitution was used for Cohorts 1 and 2, and a crossover design was used in Cohort 3. Each
cohort consisted of 12 participants, and participants were randomized to treatment sequence
to receive TAK-828 or placebo after undergoing a fasting stage of at least 8 hours through
intervention periods 1-4 for Cohorts 1 and 2 and through intervention periods 1 - 3 for
Cohort 3. The assigned treatment sequence will remain undisclosed to the participant and
study doctor during the study (unless there is an urgent medical need). An additional
interventional period 5 (fed state) is planned to be conducted in either cohort 1 or 2, based
on the dose of TAK-828 that will be chosen to be studied under fed conditions. Cohorts 1 and
2 were conducted in non-Japanese participants and Cohort 3 in Japanese participants.
This multi-center trial was conducted in the United States. Participants remained confined to
the study site from check-in (Day -1) through Day 4 of each intervention period and returned
7 to 10 days after last dose of study drug for a follow-up assessment.
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