Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-26 @ 5:18 PM
Ignite Modification Date:
2025-12-26 @ 5:18 PM
NCT ID:
NCT02322606
Brief Summary:
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of TAK-137 in healthy male subjects.
Detailed Description:
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).
Study:
NCT02322606
Study Brief:
Protocol Section:
NCT02322606