Pretomanid in Adults With Hepatic Impairment

Summary

This is a Phase 1, single dose (200 mg), open-label study comparing the pharmacokinetics and safety of Pretomanid in subjects with mild, moderate, and severe hepatic impairment to matched, non-hepatically impaired subjects. There will be approximately 36 total subjects, adult males and females, 18 to 70 years of age, inclusive. The study will be conducted at 2 sites, study duration is approximately 24 months, and subject participation duration is approximately 5 weeks (including screening). Primary objective: To evaluate the pharmacokinetics of a single oral dose of Pretomanid in subjects with mild, moderate, and severe hepatic impairment (as assessed by Child-Pugh score), relative to matched non-hepatically impaired subjects. Secondary objective: To evaluate the safety of a single oral dose of Pretomanid in subjects with mild, moderate, and severe hepatic impairment (as assessed by Child-Pugh score), relative to matched non-hepatically impaired subjects.

Timeline

Start

2018-03-29

Primary completion

2023-08-26

Completion

2023-11-17

Outcome

Outcome not reported

Stopped (Enrollment): “The TB hepatic pretomanid PK trial is closed to enrollment. There is no possibility of enrolling and completing the CSR before November 2024.”

Drugs

Indications