Study of Bemnifosbuvir in Subjects With Normal and Impaired Hepatic Function

To Assess the Effect of Hepatic Impairment on the Pharmacokinetics of Bemnifosbuvir After a Single Dose

Inclusion Criteria:Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drugFemales must have a negative pregnancy test at Screening and prior to dosingBMI of 18.5 to 42.0 kg/m2Willing to comply with the study requirements and to provide written informed consentSubjects with Normal Hepatic Function (Groups 3 and 5):Medically healthy, in the opinion of an InvestigatorMust match by gender, age (± 10 years), and BMI (± 20%) to the pooled mean values of subjects with hepatic impairmentHepatic Impaired Subjects (Groups 1, 2, and 4):Considered stable for at least 1 month prior to Screening, as per the judgement of an InvestigatorWhen applicable, presence of mild hepatic impairment (Child-Pugh Class A: score of 5 to 6), moderate hepatic impairment (Child-Pugh Class B: score of 7 to 9) or severe hepatic impairment (Child-Pugh Class C: score of 10 to 15). Hepatic impairment should be stable for at least 1 month prior to ScreeningExclusion Criteria:Pregnant or breastfeedingInfected with hepatitis B virus, hepatitis C virus, HIV or COVID-19Abuse of alcohol or drugsUse of other investigational drugs within 28 days of dosingOther clinically significant medical conditions or laboratory abnormalitiesHepatic Impaired Subjects (Groups 1, 2, and 4):Currently undergoing any method of dialysisHistory of liver transplantPresence of poorly controlled Type 1 or Type 2 diabetes as defined by Hemoglobin A1c (HbA1c) > 10%Evidence of hepatic carcinoma presence at Screening