Healthy Volunteers Clinical Trial
Official title:
An Open-Label, Phase 1 Study to Compare Pharmacokinetics, Safety, and Tolerability of a Single Oral Dose of TAK-279 in Subjects With or Without Hepatic Impairment
The main aim of this study is to find out how the body processes 1 dose of TAK-279 (pharmacokinetics) in participants with liver problems compared to participants without liver problems. Other aims are to check for side effects from TAK-279 and to learn how well participants tolerate 1 dose of TAK-279. The participants will need to stay at the clinic for 11 days.
The drug being tested in this study is called TAK-279. The study will assess the safety and tolerability of single oral dose of TAK-279 in participants with moderate (Part A) and mild or severe (Part B) hepatic impairment (HI) compared to healthy participants with normal hepatic function. The study will enroll up to 32 participants. Participants will be assigned to following study arms: - Cohort 1, Moderate HI: TAK-279 50 mg - Cohort 2, Normal Hepatic Function: TAK-279 50 mg - Cohort 3, Mild/Severe HI: TAK-279 50 mg This multi-center trial will be conducted in the United States. The overall duration of the study is approximately 42 days. Participants will be followed up for 14 days after the last dose of study drug for a follow-up assessment. ;
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