NCT06921941

Drug-drug Interaction Study of Bemnifosbuvir/Ruzasvir (BEM/RZR) and Digoxin and Rosuvastatin

A Phase 1, Open-Label, Two-Part Study to Evaluate the Effect of a Single Oral Dose of Bemnifosbuvir/Ruzasvir Fixed Dose Combination on the Pharmacokinetics of Digoxin and Rosuvastatin in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Atea Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Drug-drug interaction study between Bemnifosbuvir/Ruzasvir and Digoxin or Rosuvastatin

Conditions

• Healthy Volunteer Study

Interventions

Type	Name	Description
DRUG	Digoxin vs Digoxin + BEM/RZR vs Digoxin + 2h BEM/RZR	Treatment-A (Digoxin): A single dose of digoxin will be administered under fasting conditions. Treatment-B (Digoxin + BEM/RZR): A single dose of digoxin will be co-administered a single dose of BEM/RZR under fasting conditions. Treatment-C (Digoxin + 2h BEM/RZR): A single dose of digoxin will be administered under fasting conditions. Then, a single dose of BEM/RZR will be administered approximately 2 hours later under fasting conditions.
DRUG	Rosuvastatin vs Rosuvastatin + BEM/RZR vs Rosuvastatin + 2h BEM/RZR	Treatment-D (rosuvastatin): A single dose of rosuvastatin will be administered under fasting conditions. Treatment-E (rosuvastatin + BEM/RZR): A single dose of rosuvastatin will be co-administered with a single dose BEM/RZR under fasting conditions. Treatment-F (rosuvastatin + 2h BEM/RZR): A single dose of rosuvastatin will be administered under fasting conditions. Then, a single dose BEM/RZR will be administered approximately 2 hours later under fasting conditions.

Timeline

• Start date: 2025-04-08
• Primary completion: 2025-07-02
• Completion: 2025-07-02
• First posted: 2025-04-10
• Last updated: 2025-08-29

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study