NCT06911320

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Atea Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

To Assess the Effect of Severe Hepatic or Renal Impairment on the Pharmacokinetics of Bemnifosbuvir/Ruzasvir After a Single Dose

Conditions

• Healthy Volunteer Study
• Hepatic Impairment
• Renal Impairment

Interventions

Type	Name	Description
DRUG	Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination	A single dose of BEM/RZR will be administered

Timeline

• Start date: 2025-04-09
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2025-04-04
• Last updated: 2026-04-13

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study