Overview
To Assess the Effect of Severe Hepatic or Renal Impairment on the Pharmacokinetics of Bemnifosbuvir/Ruzasvir 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 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