Pharmacokinetics Clinical Trial
Official title:
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Sequential-Cohort, Ascending Multiple Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MLN3126 in Healthy Non-Japanese and Japanese Subjects
The purpose of this study is to evaluate the safety and tolerability of single and multiple oral dosing of MLN3126 in ascending doses in healthy non-Japanese and Japanese participants.
MLN3126 is being tested to find a safe and well-tolerated dose in healthy people and to
assess how MLN3126 is processed by the body. In total, approximately 64 participants will be
enrolled in the study.
This study is composed of 2 parts: Part A healthy non-Japanese participants and Part B
healthy Japanese participants. Each part will consist of 4 Cohorts with 8 participants in
each Cohort. In each Cohort, 6 participants will receive MLN3126 and 2 participants will
receive matched placebo within 30 minutes after the start of a standard breakfast. The
starting dose will be 100 mg followed by doses of 300 mg, 800 mg, and a dose to be
determined during the study. Progression to the next dose level will only occur if the
previous dose level was considered to be safe and well tolerated.
This single-center trial will be conducted in the United States. The overall time to
participate in this study is up to 20 days. All participants will be contacted by telephone
7 days after the last dose of study drug for a follow-up assessment.
Due to toxicology findings from a long-term animal study, Takeda made the decision to
terminate this study. No clinically significant safety and/or tolerability issues have been
observed or reported in participants exposed to MLN3126.
;
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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