Healthy Volunteer Study
Conditions
Brief summary
Drug-drug interaction study between Ethinyl Estradioll/Levonorgestrel and Bemnifosbuvir/Ruzasvir
Interventions
DRUGEthinyl 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.
DRUGBemnifosbuvir/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.
DRUGBemnifosbuvir/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.
Sponsors
Atea Pharmaceuticals, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK of EE/LNG (Cmax) | Day 1,15 |
| PK of EE/LNG (AUC) | Day 1,15 |
Countries
Canada
Outcome results
None listed