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.
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
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
Parallel
Ulonivirine
DrugFour ulonivirine 100 mg tablets (total dose 400 mg) taken by mouth.
Area Under the Plasma Concentration-Time Curve from Dosing to Infinity (AUC0-∞) of Ulonivirine
The AUC0-∞ of ulonivirine will be determined in participants with mild or moderate HI and healthy controls.
Area Under the Plasma Concentration-Time Curve from Dosing to Last Measurable Concentration (AUC0-last) of Ulonivirine
The AUC0-last of ulonivirine will be determined in participants with mild or moderate HI and healthy controls.
Maximum Plasma Concentration (Cmax) of Ulonivirine
The Cmax of ulonivirine will be determined in participants with mild or moderate HI and healthy controls.
Time to Maximum Plasma Concentration (Tmax) of Ulonivirine
The Tmax of ulonivirine will be determined in participants with mild or moderate HI and healthy controls.
Percentage of Participants with an Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
