Healthy Volunteers Clinical Trial
Official title:
A Phase 1 Study to Assess Absolute Bioavailability of TAK-994 and to Characterize Mass Balance, Pharmacokinetics, Absorption, Metabolism, and Excretion of [14C]TAK-994 in Male Healthy Subjects
The aim of this study is to understand how TAK-994 is processed by the body. This study will require participants to stay at the clinical research unit for 3 weeks to be monitored after receiving TAK-994.
The drug being tested in this study is called TAK-994. TAK-994 is being tested in healthy male participants. This study will characterize how TAK -994 is absorbed, metabolize, excreted by the body, after single oral administration by collecting plasma, urine, and feces samples for testing. The study will enroll approximately 6 participants. The study consists of 2 parts: Part A and Part B. In Part A, all participants will receive TAK-994 as tablet and [14C]TAK-994 as intravenous infusion. In Part B, all participants will receive a single dose of [14C]TAK-994 as an oral suspension. This single-center trial will be conducted in the United States. The overall time to participate in this study is approximately 67 days, including a 28-day screening period plus approximately 30 days for follow up. ;
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