NCT07272889

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Atea Pharmaceuticals, Inc. · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Healthy Volunteer Study

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2025-12-04
• Primary completion: 2026-02-17
• Completion: 2026-02-17
• First posted: 2025-12-09
• Last updated: 2026-04-13

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study