Healthy Volunteer Study, Hepatic Impairment, Renal Impairment
Conditions
Brief summary
To Assess the Effect of Severe Hepatic or Renal Impairment on the Pharmacokinetics of Bemnifosbuvir/Ruzasvir After a Single Dose
Interventions
DRUGBemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination
A single dose of BEM/RZR will be administered
Sponsors
Atea Pharmaceuticals, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (PK) of BEM/RZR Maximum plasma concentration (Cmax) | Day 1 |
| Pharmacokinetics (PK) of BEM/RZR Area under the plasma concentration-time curve (AUC) | Day 1 |
| Pharmacokinetics (PK) of BEM/RZR AUC | Day 1 |
Countries
United States
Outcome results
None listed