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

Phase 1

Completed

• Conditions: Healthy Volunteer Study
• Interventions: Drug: Digoxin vs Digoxin + BEM/RZR vs Digoxin + 2h BEM/RZR; Drug: Rosuvastatin vs Rosuvastatin + BEM/RZR vs Rosuvastatin + 2h BEM/RZR

• Registration Number: NCT06921941
• Lead Sponsor: Atea Pharmaceuticals, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-27
• Study First Submitted QC: 2025-04-03
• Study Start: 2025-04-08
• Study First Posted: 2025-04-10
• Primary Completion: 2025-07-02
• Study Completion: 2025-07-02
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-25
• Last Update Posted: 2025-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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.
• Minimum body weight of 50 kg and body mass index (BMI) of 18-30 kg/m2.
• Willing to comply with the study requirements and to provide written informed consent.

Exclusion Criteria

• Infected with hepatitis B virus, hepatitis C virus, HIV or SARS-CoV-2.
• Abuse of alcohol or drugs.
• Use of other investigational drugs within 28 days of dosing.
• Concomitant use of prescription medications, or systemic over-the-counter medications.
• Other clinically significant medical conditions or laboratory abnormalities.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Digoxin vs Digoxin + BEM/RZR vs Digoxin + 2h BEM/RZR	Digoxin vs Digoxin + BEM/RZR vs Digoxin + 2h BEM/RZR	-
Rosuvastatin vs Rosuvastatin + BEM/RZR vs Rosuvastatin + 2h BEM/RZR	Rosuvastatin vs Rosuvastatin + BEM/RZR vs Rosuvastatin + 2h BEM/RZR	-

Primary Outcome Measures

Name	Time	Method
PK of Digoxin and Rosuvastatin (Cmax)	Digoxin: Days 1,15, 29; Rosuvastatin: Days 1, 8, 15
PK of Digoxin and Rosuvastatin (AUC)	Digoxin: Days 1,15, 29; Rosuvastatin: Days 1, 8, 15

Trial Locations

Locations (1)

Atea Study Site; 🇨🇦 Québec, Montreal, Canada