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Drug-drug Interaction Study of Bemnifosbuvir/Ruzasvir (BEM/RZR) and Ethinyl Estradiol/Levonorgestrel (EE/LNG)
Sponsor: Atea Pharmaceuticals, Inc.
Summary
Drug-drug interaction study between Ethinyl Estradioll/Levonorgestrel and Bemnifosbuvir/Ruzasvir
Official 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
Key Details
Gender
FEMALE
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2025-12
Completion Date
2025-12
Last Updated
2025-12-09
Healthy Volunteers
Yes
Conditions
Interventions
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.
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.
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.
Locations (1)
Atea Study Site
Québec, Montreal, Canada