Dose Finding Study Clinical Trial
Official title:
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAK-438 in Healthy Male Subjects
The purpose of this study was to evaluate the safety and pharmacokinetics of TAK-438 following multiple oral doses to healthy adult Japanese male participants
The drug being tested in this study is called TAK-438. TAK-438 was being tested to assess
side effects and how TAK-438 moves throughout the body after multiple doses have been
administered. This study looked at lab results and side effects in people who took TAK-438.
The study consisted of 5 steps covering dose ranges of TAK-438 from 10, 15, 20, 30 and 40 mg
once daily for 7 days. The study population for each step included 12 participants. Within
each step, 9 participants were randomized to TAK-438 and 3 participants were randomized to
placebo. A total of 60 participants were enrolled.
The dosing groups in this study took place in sequential order. Therefore, the TAK-438 15 mg
group did not start until the TAK-439 10 mg group had completed, etc. All participants in
each dosing group were asked to take the study drug in the morning, after fasting for at
least 10 hours, each day throughout the study.
This single-centre trial was conducted in the Japan. The overall time to participate in this
study was up to 43 days. Participants made 3 visits to the clinic, including one 11-day
period of confinement to the clinic, and a final visit 7 days after last dose of study drug
for a follow-up assessment.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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