NCT05976321

A Study of TAK-279 in Adults With or Without Liver Damage

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Hepatic Impairment
• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	TAK-279	TAK-279 capsules.

Timeline

• Start date: 2023-09-22
• Primary completion: 2024-04-15
• Completion: 2024-04-15
• First posted: 2023-08-04
• Last updated: 2024-08-29

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study