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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Four 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.
Time frame: Predose and 1, 2, 4, 6, 8, 12, 24, 48, 96, 120, 168, 240, 336, and 504 hours postdose
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.
Time frame: Predose and 1, 2, 4, 6, 8, 12, 24, 48, 96, 120, 168, 240, 336, and 504 hours postdose
Maximum Plasma Concentration (Cmax) of Ulonivirine
The Cmax of ulonivirine will be determined in participants with mild or moderate HI and healthy controls.
Time frame: Predose and 1, 2, 4, 6, 8, 12, 24, 48, 96, 120, 168, 240, 336, and 504 hours postdose
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.
Time frame: Predose and 1, 2, 4, 6, 8, 12, 24, 48, 96, 120, 168, 240, 336, and 504 hours postdose
Apparent Plasma Terminal Half-life (t½) of Ulonivirine
The t½ of ulonivirine will be determined in participants with mild or moderate HI and healthy controls.
Time frame: Predose and 1, 2, 4, 6, 8, 12, 24, 48, 96, 120, 168, 240, 336, and 504 hours postdose
Apparent Total Clearance from Plasma After Oral Administration (CL/F) of Ulonivirine
The CL/F of ulonivirine will be determined in participants with mild or moderate HI and healthy controls.
Time frame: Predose and 1, 2, 4, 6, 8, 12, 24, 48, 96, 120, 168, 240, 336, and 504 hours postdose
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Apparent Volume of Distribution during Terminal Phase (Vz/F) of Ulonivirine
The Vz/F of ulonivirine will be determined in participants with mild or moderate HI and healthy controls.
Time frame: Predose and 1, 2, 4, 6, 8, 12, 24, 48, 96, 120, 168, 240, 336, and 504 hours postdose
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.
Time frame: Up to 21 days