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

Atea Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer Study

Treatments: Drug: Digoxin vs Digoxin + BEM/RZR vs Digoxin + 2h BEM/RZR; Drug: Rosuvastatin vs Rosuvastatin + BEM/RZR vs Rosuvastatin + 2h BEM/RZR

Study type: Interventional

Funder types: Industry

Identifiers

NCT06921941

AT-01B-009

Details and patient eligibility

About

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

Enrollment: 38 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

Digoxin vs Digoxin + BEM/RZR vs Digoxin + 2h BEM/RZR

Experimental group

Treatment:

Drug: Digoxin vs Digoxin + BEM/RZR vs Digoxin + 2h BEM/RZR

Rosuvastatin vs Rosuvastatin + BEM/RZR vs Rosuvastatin + 2h BEM/RZR

Experimental group

Treatment:

Drug: Rosuvastatin vs Rosuvastatin + BEM/RZR vs Rosuvastatin + 2h BEM/RZR