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
Atea Pharmaceuticals, Inc.
Summary
To Assess the Effect of Severe Hepatic or Renal Impairment on the Pharmacokinetics of Bemnifosbuvir/Ruzasvir After a Single Dose
Eligibility
- Age range
- 18–80 years
- Sex
- All
- 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 lea…
Interventions
- DrugBemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination
A single dose of BEM/RZR will be administered
Locations (2)
- Atea Study SiteOrlando, Florida
- Atea Study SiteTampa, Florida