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Completed

NCT Number: NCT07272889

Drug-drug Interaction Study of Bemnifosbuvir/Ruzasvir (BEM/RZR) and Ethinyl Estradiol/Levonorgestrel (EE/LNG)

Drug-drug interaction study between Ethinyl Estradioll/Levonorgestrel and Bemnifosbuvir/Ruzasvir

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Key information

Conditions

Healthy Volunteer Study

Age range

18 year–65 year

Sex eligibility

Female

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

  • Healthy post-menopausal or hormonally sterile female
  • Minimum body weight of 50 kg and body mass index (BMI) of 18.0-30 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

Ethinyl Estradioll/Levonorgestrel (EE/LNG)

Drug

Treatment-A (EE/LNG): A single 0.03 mg/ 0.15 mg dose of EE/LNG (1 × 0.03 mg/ 0.15 mg tablet) will be administered in the morning under fasting conditions on Day 1.

Other names: Portia® 21

Bemnifosbuvir/Ruzasvir (BEM/RZR)

Drug

Treatment-B (BEM/RZR): A 550 mg/180 mg dose of BEM/RZR (2 × 275 mg/90 mg BEM/RZR FDC tablets) will be administered once daily (QD) under fasting conditions on Days 8 to 14.

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

Bemnifosbuvir/Ruzasvir (BEM/RZR) + Ethinyl Estradioll/Levonorgestrel (EE/LNG)

Drug

Treatment-C (BEM/RZR + EE/LNG): BEM (550 mg)/ RZR (180 mg) as 2 × 275 mg/90 mg BEM/RZR FDC tablets will be administered QD in the morning under fasting conditions on Days 15 to 19. A single 0.03 mg/0.15 mg dose of EE/LNG (1 × 0.03 mg/ 0.15 mg tablet) will be concomitantly administered with BEM/RZR on the morning of Day 15.

Other names: BEM (AT-527)/RZR (AT-038), Portia® 21

Primary outcomes

  1. PK of EE/LNG (Cmax)

    Time frame: Day 1,15

  2. PK of EE/LNG (AUC)

    Time frame: Day 1,15

Sponsors and collaborators

Lead sponsor

Atea Pharmaceuticals, Inc.

Industry

Registry information

Official study title

A Phase 1, Open-Label Study to Evaluate the Effect of Multiple Oral Doses of Bemnifosbuvir/Ruzasvir Fixed-dose Combination on the Single-Dose Pharmacokinetics of a Combined Oral Contraceptive (Ethinyl Estradiol/ Levonorgestrel) in Healthy Adult Female Participants of Non-Childbearing Potential

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 9, 2025
Registry last updated
Apr 13, 2026

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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