Drug-drug Interaction Study of Ruzasvir and Bemnifosbuvir
Phase 1
Completed
- Conditions
- Healthy Volunteer Study
- Interventions
- Drug: Cohort 1 BEM + RuzasvirDrug: Cohort 2 Ruzasvir + BEM
- Registration Number
- NCT05731843
- Lead Sponsor
- Atea Pharmaceuticals, Inc.
- Brief Summary
Drug-drug interaction study of Ruzasvir and Bemnifosbuvir
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
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 18-29 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
- PARALLEL
- Arm && Interventions
Group Intervention Description BEM vs BEM + Ruzasvir n=16 Cohort 1 BEM + Ruzasvir - Ruzasvir vs Ruzasvir + BEM n=16 Cohort 2 Ruzasvir + BEM -
- Primary Outcome Measures
Name Time Method Pharmacokinetics (PK) of BEM Days 6, 12, 18 Maximum plasma concentration (Cmax) and Area under the plasma concentration-time curve (AUC)
Pharmacokinetics (PK) of Ruzasvir Days 6, 12, 18 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, Quebec, Canada