This is a Phase 1, single dose (200 mg), open-label, sequential group 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.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)