Pharmacokinetics of Fixed-Dose Combination Tablet of Bemnifosbuvir and Ruzasvir
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
1 other identifier
interventional
42
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Dec 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 14, 2023
CompletedFirst Submitted
Initial submission to the registry
January 2, 2024
CompletedFirst Posted
Study publicly available on registry
January 12, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 25, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 25, 2024
CompletedSeptember 19, 2024
September 1, 2024
9 months
January 2, 2024
September 11, 2024
Conditions
Outcome Measures
Primary Outcomes (4)
Pharmacokinetics (PK) of FDC compared to reference:(Cmax)
Maximum plasma concentration (Cmax)
Day 1, Day 7, Day 13
Pharmacokinetics (PK) of FDC compared to reference:(AUC)
Area under the plasma concentration-time curve (AUC)
Day 1, Day 7, Day 13
Food effect of Fixed Dose Combination of Bemnifosbuvir (BEM)/Ruzasvir (RZR):(Cmax)
Maximum plasma concentration (Cmax)
Day 1, Day 7, Day 13
Food effect of Fixed Dose Combination of Bemnifosbuvir (BEM)/Ruzasvir (RZR):(AUC)
Area under the plasma concentration-time curve (AUC)
Day 1, Day 7, Day 13
Study Arms (3)
FDC Fasting
EXPERIMENTALDay 1, Day 7, Day 13
FDC Fed
EXPERIMENTALDay 1, Day 7, Day 13
Reference Fasting
EXPERIMENTALDay 1, Day 7, Day 13
Interventions
A Fixed-Dose Combination of Bemnifosbuvir (BEM) and Ruzasvir (RZR)
A Fixed-Dose Combination of Bemnifosbuvir (BEM) and Ruzasvir (RZR)
Bemnifosbuvir (BEM) and Ruzasvir (RZR) as separate formulations
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Atea Study Site
Cypress, California, 90630, United States
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 2, 2024
First Posted
January 12, 2024
Study Start
December 14, 2023
Primary Completion
August 25, 2024
Study Completion
August 25, 2024
Last Updated
September 19, 2024
Record last verified: 2024-09