Study of Bemnifosbuvir/Ruzasvir as a Fixed-dose Combination in Subjects With Normal or Severely Impaired Renal or Hepatic Function

A Phase 1, Open-Label, Parallel-Group, Single-Dose Study to Evaluate the Safety and Pharmacokinetics of Bemnifosbuvir and Ruzasvir Administered as a Fixed-Dose Combination in Adult Participants With Severe Renal or Hepatic Impairment in Comparison to Healthy Participants

To Assess the Effect of Severe Hepatic or Renal Impairment on the Pharmacokinetics of Bemnifosbuvir/Ruzasvir 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 43.0 kg/m2
• Willing to comply with the study requirements and to provide written informed consent

Renal Impaired Subjects (Group 1):

• Considered stable in the judgement of an Investigator
• Presence of severe renal impairment or kidney failure (as defined by eGFR< 30 mL/ min)

Hepatic Impaired Subjects (Group 2):

• Considered stable for at least 1 month prior to Screening, as per the judgement of an Investigator
• Presence of severe hepatic impairment (Child-Pugh Class C: score of 10 to 15).

Subjects with Normal Hepatic and Renal Function (Group 3):

• Medically healthy, in the opinion of an Investigator
• Must match by gender, age (± 10 years), and BMI (within 20%) to the pooled mean values of subjects with severe renal and hepatic impairment

Exclusion Criteria:

• Pregnant or breastfeeding
• Infected with hepatitis B virus, hepatitis C virus or HIV
• Abuse of alcohol or drugs
• Use of other investigational drugs within 28 days of dosing
• Other clinically significant medical conditions or laboratory abnormalities

Renal and Hepatic Impaired Subjects (Group 1 and 2):

• Presence of poorly controlled Type 1 or Type 2 diabetes as defined by Hemoglobin A1c > 10%
• Undergoing any method of dialysis
• Subjects requiring treatment for hepatic impairment or other chronic disease must be on a stable treatment plan

Renal Impaired Subjects (Group 1):

• History of renal transplant
• Concurrent use of medications known to affect the elimination of serum creatinine

Hepatic Impaired Subjects (Group 2):

• History of liver transplant
• Evidence of hepatic carcinoma presence at Screening