A Phase 1, Open-Label Study to Assess Comparative Bioavailability and Effect of Food on a Prototype Fixed-Dose Combination of Bemnifosbuvir and Ruzasvir Versus Individual Dosage Forms Taken Concomitantly in Healthy Adult Subjects
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Atea Pharmaceuticals, Inc.
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Pharmacokinetics (PK) of FDC compared to reference:(Cmax)
Study Overview
Brief Summary
This study will assess comparative bioavailability and effect of food on a prototype fixed-dose combination (FDC) of Bemnifosbuvir (BEM) and Ruzasvir (RZR) in healthy subjects
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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/m
- •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-
- •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.
Arms & Interventions
FDC Fasting
Day 1, Day 7, Day 13
Intervention: Bemnifosbuvir (BEM)/Ruzasvir (RZR) FDC under fasting conditions (Drug)
FDC Fed
Day 1, Day 7, Day 13
Intervention: Bemnifosbuvir (BEM)/Ruzasvir (RZR) FDC under fed conditions (Drug)
Reference Fasting
Day 1, Day 7, Day 13
Intervention: Bemnifosbuvir (BEM) and Ruzasvir (RZR) as reference formulation under fasting conditions (Drug)
Outcomes
Primary Outcomes
Pharmacokinetics (PK) of FDC compared to reference:(Cmax)
Time Frame: Day 1, Day 7, Day 13
Maximum plasma concentration (Cmax)
Food effect of Fixed Dose Combination of Bemnifosbuvir (BEM)/Ruzasvir (RZR):(AUC)
Time Frame: Day 1, Day 7, Day 13
Area under the plasma concentration-time curve (AUC)
Food effect of Fixed Dose Combination of Bemnifosbuvir (BEM)/Ruzasvir (RZR):(Cmax)
Time Frame: Day 1, Day 7, Day 13
Maximum plasma concentration (Cmax)
Pharmacokinetics (PK) of FDC compared to reference:(AUC)
Time Frame: Day 1, Day 7, Day 13
Area under the plasma concentration-time curve (AUC)
Secondary Outcomes
No secondary outcomes reported