Drug-drug Interaction Study of Biktarvy and Bemnifosbuvir/Ruzasvir
Phase 1
Completed
- Conditions
- Healthy Volunteer Study
- Registration Number
- NCT06356194
- Lead Sponsor
- Atea Pharmaceuticals, Inc.
- Brief Summary
Drug-drug interaction study of Biktarvy and Bemnifosbuvir/Ruzasvir
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
Inclusion Criteria
- Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug.
- Minimum body weight of 50 kg and body mass index (BMI) of 18-30 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method PK of Biktarvy (BIK: Bictegravir, tenofovir alafenamide, emtricitabine) on the pharmacokinetics (PK) of Bemnifosbuvir (BEM) and Ruzasvir (RZR). Day 2, Days 4-7, Days 14-17, Days 21-24 Maximum plasma concentration (Cmax) and Area under the plasma concentration-time curve (AUC)
To determine the effect of Bemnifosbuvir (BEM)/Ruzasvir (RZR) combination on the PK of Biktarvy (BIK: Bictegravir, tenofovir alafenamide, emtricitabine) Days 7-10, Day 12, Days 14-17, Days 21-24. Maximum plasma concentration (Cmax) and Area under the plasma concentration-time curve (AUC)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Atea Study Site
🇨🇦Québec, Montreal, Canada