Pretomanid in Adults With Hepatic Impairment

Inclusion criteria

• ✓. Subject is able to give voluntary written informed consent before any study related procedure is performed.
• ✓. 18-70 years of age, inclusive.
• ✓. Acceptable laboratory values\* obtained at screening (within 21 days prior to admission to the confinement/hospital unit) and either at or within 72 hours of admission to the confinement/hospital unit.
• ✓. Hepatic impairment classified as Child-Pugh class A (mild), B (moderate), or C (severe) criteria at screening for Groups 1, 2, or 3, respectively, and documented evidence of hepatic cirrhosis\*.
• ✓. If female, not of childbearing potential\* or agrees to avoid becoming pregnant by using acceptable contraception\*\* during the duration of the study.
• ✓. If subject is male and capable of reproduction, agrees to avoid fathering a child for three months after dosing by using an acceptable method of birth control\*.
• ✓. If the subject is female, a negative serum pregnancy test at screening and a negative urine pregnancy test at admission to the confinement/hospital unit.
• ✓. Willingness to comply with all protocol requirements.

Exclusion criteria