Healthy Japanese Adult Male Clinical Trial
Official title:
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of TAK-137 in Healthy Subjects
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of TAK-137 in healthy male subjects.
This study is a phase 1, randomized, placebo-controlled, double-blind, multiple ascending
dose study in Japanese healthy male participants to assess the safety, tolerability and PK
following single and multiple oral doses of TAK-137.
This study is composed of 2 parts, a Single Dose part (Cohorts 1 to 3) and a Multiple Dose
part (Cohorts 4 to 6). Up to 48 participants will be enrolled.
Single dose part (Cohorts 1-3): Single Dose, 3 dose levels, Placebo-Controlled, Randomized,
Double-Blind.
Each cohort will include 8 participants. Participants will be randomly assigned to either
TAK-137 or placebo treatment group within each cohort with an allocation ratio of 6:2.
The planned dose levels to be studied are 5, 10 and 20 mg. The principal investigator will
consult with the sponsor and the medical specialist as needed and will determine go/no-go
for the next cohort.. The dose in Cohorts 3 may be reduced to 2 mg/day instead of 20 mg/day
if the principal investigator, in consultation with the sponsor, considers it appropriate.
Multiple dose Part (Cohorts 4-6): Multiple Dose, 3 dose levels, Placebo-Controlled,
Randomized, Double-Blind.
Each cohort will include 8 participants. Participants will be randomly assigned to either
TAK-137 or placebo treatment group within each cohort with an allocation ratio of 6:2.
The planned dose levels to be studied are 5, 10,and 15 mg, however for Cohort 5 and 6, the
dose level may be amended based on the safety and tolerability data obtained from either
Cohorts 1-4 from this study or emerging data from the multiple rising dose study conducted,
in parallel in the United Sates (TAK-137_102). The principle investigator, in consultation
with the sponsor, will determine the dose levels for cohorts 5 and 6 (Not exceeding 20mg).
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment