About this trial
The purpose of this study is to evaluate pharmacokinetics (PK) and safety of a single oral dose of ulonivirine in participants with mild or moderate hepatic impairment (HI). It is hypothesized that the area under the plasma concentration-time curve from dosing to (extrapolated) infinity (AUC0-∞) in participants with mild or moderate HI is similar to that of healthy control participants.
Eligibility criteria
Qualifiers
Has a diagnosis of chronic (>6 months), stable HI with features of cirrhosis due to any etiology (stability of hepatic disease should correspond to no acute episodes of illness within the previous 2 months due to deterioration in hepatic function)
Is in good health
Has a body mass index (BMI) ≥18.5 and ≤40 kg/m², inclusive
If male, uses contraception in accordance with local regulations
Disqualifiers
Has a history of any illness that, in the opinion of the investigator, might confound the results of the study or poses an additional risk to the participant by their participation in the study
Is not in sufficient health
Is institutionalized/mentally or legally incapacitated
Is positive for human immunodeficiency virus (HIV)-1 or HIV-2
Trial design
Treatments tested in this trial
- Ulonivirine