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Completed

NCT Number: NCT06921941

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

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

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Key information

Conditions

Healthy Volunteer Study

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Atea Study Site

Québec, Montreal, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

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.

Other names: AT-527 (BEM) and AT-038 (RZR)

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

Drug

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.

Other names: AT-527 (BEM) and AT-038 (RZR)

Primary outcomes

  1. PK of Digoxin and Rosuvastatin (Cmax)

    Time frame: Digoxin: Days 1,15, 29; Rosuvastatin: Days 1, 8, 15

  2. PK of Digoxin and Rosuvastatin (AUC)

    Time frame: Digoxin: Days 1,15, 29; Rosuvastatin: Days 1, 8, 15

Sponsors and collaborators

Lead sponsor

Atea Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 10, 2025
Registry last updated
Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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