Study of Bemnifosbuvir in Subjects With Normal and Impaired Hepatic Function

A Phase 1, Multicenter, Open-Label, Parallel-Group, Pharmacokinetic Single Dose Study of Bemnifosbuvir (AT-527) in Adult 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 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