Drug-drug Interaction Study of Bemnifosbuvir/Ruzasvir (BEM/RZR) and Ethinyl Estradiol/Levonorgestrel (EE/LNG)
NCT07272889 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2026-04-13
Summary
Drug-drug interaction study between Ethinyl Estradioll/Levonorgestrel and Bemnifosbuvir/Ruzasvir
Conditions
- Healthy Volunteer Study
Interventions
- DRUG
-
Bemnifosbuvir/Ruzasvir (BEM/RZR)
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.
- DRUG
-
Bemnifosbuvir/Ruzasvir (BEM/RZR) + Ethinyl Estradioll/Levonorgestrel (EE/LNG)
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.
- DRUG
-
Ethinyl Estradioll/Levonorgestrel (EE/LNG)
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.
Sponsors & Collaborators
-
Atea Pharmaceuticals, Inc.
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-12-04
- Primary Completion
- 2026-02-17
- Completion
- 2026-02-17
- FDA Drug
- Yes
Countries
- Canada
Study Locations
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