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Safety, Tolerability and Pharmacokinetics of Escalating Single Doses of TAK-828 in Healthy Participants

2016-03-15 04:35:53 | BioPortfolio

Summary

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.

Description

The drug being tested in this study is called TAK-828. TAK-828 is being tested to evaluate the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) of single oral doses of TAK-828 in healthy non-Japanese and Japanese participants.

The study will enroll approximately 36 healthy participants. An interleaving crossover design with placebo substitution will be used for Cohorts 1-3. Each cohort will consist of 12 participants, randomly assigned (by chance, like flipping a coin) to a 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 will be conducted in The United States. Participants will remain confined to the study site from check-in (Day -1) through Day 4 of each intervention period and will return 7 to 10 days after last dose of study drug for a follow-up assessment.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Conditions

Dose Finding Study

Intervention

Group A1= TAK-828 0.1 mg+TAK-828 3 mg +TAK-828 20 mg +Placebo, Group B1= TAK-828 0.1 mg+TAK-828 3 mg+Placebo+TAK-828 100 mg, Group C1= TAK-828 0.1 mg+Placebo+TAK-828 20 mg+TAK-828 100 mg, Group D1= Placebo+TAK-828 3 mg+TAK-828 20 mg+TAK-828 100 mg, Group

Status

Not yet recruiting

Source

Takeda

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-03-15T04:35:53-0400

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