Overview
To Assess the Effect of Hepatic Impairment on the Pharmacokinetics of Bemnifosbuvir After a Single Dose
Eligibility
Inclusion Criteria:
- Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug
- Females must have a negative pregnancy test at Screening and prior to dosing
- BMI of 18.5 to 42.0 kg/m2
- Willing to comply with the study requirements and to provide written informed consent
Subjects with Normal Hepatic Function (Groups 3 and 5):
- Medically healthy, in the opinion of an Investigator
- Must match by gender, age (± 10 years), and BMI (± 20%) to the pooled mean values of subjects with hepatic impairment
Hepatic Impaired Subjects (Groups 1, 2, and 4):
- Considered stable for at least 1 month prior to Screening, as per the judgement of an Investigator
- When 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 Screening
Exclusion Criteria:
- Pregnant or breastfeeding
- Infected with hepatitis B virus, hepatitis C virus, HIV or COVID-19
- Abuse of alcohol or drugs
- Use of other investigational drugs within 28 days of dosing
- Other clinically significant medical conditions or laboratory abnormalities
Hepatic Impaired Subjects (Groups 1, 2, and 4):
- Currently undergoing any method of dialysis
- History of liver transplant
- Presence of poorly controlled Type 1 or Type 2 diabetes as defined by Hemoglobin A1c (HbA1c) > 10%
- Evidence of hepatic carcinoma presence at Screening