Drug-drug Interaction Study of Biktarvy and Bemnifosbuvir/Ruzasvir
A Phase 1, Open-Label, Multiple Dose Study to Evaluate the Drug-Drug Interaction Potential Between Bemnifosbuvir/Ruzasvir and Bictegravir/Emtricitabine/Tenofovir Alafenamide (Biktarvy®) in Healthy Adult Subjects
1 other identifier
interventional
28
1 country
1
Brief Summary
Drug-drug interaction study of Biktarvy and Bemnifosbuvir/Ruzasvir
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Apr 2024
Shorter than P25 for phase_1
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
First Submitted
Initial submission to the registry
April 4, 2024
CompletedFirst Posted
Study publicly available on registry
April 10, 2024
CompletedStudy Start
First participant enrolled
April 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2024
CompletedJuly 31, 2024
July 1, 2024
2 months
April 4, 2024
July 29, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
PK of Biktarvy (BIK: Bictegravir, tenofovir alafenamide, emtricitabine) on the pharmacokinetics (PK) of Bemnifosbuvir (BEM) and Ruzasvir (RZR).
Maximum plasma concentration (Cmax) and Area under the plasma concentration-time curve (AUC)
Day 2, Days 4-7, Days 14-17, Days 21-24
To determine the effect of Bemnifosbuvir (BEM)/Ruzasvir (RZR) combination on the PK of Biktarvy (BIK: Bictegravir, tenofovir alafenamide, emtricitabine)
Maximum plasma concentration (Cmax) and Area under the plasma concentration-time curve (AUC)
Days 7-10, Day 12, Days 14-17, Days 21-24.
Study Arms (2)
BEM/RZR vs BEM/RZR + BIK vs BIK
EXPERIMENTALn=14
BIK vs BEM/RZR + BIK vs BEM/RZR
EXPERIMENTALn=14
Interventions
A co-administered dose of Bemnifosbuvir (BEM)/Ruzasvir (RZR) as separate formulations and Biktarvy (BIK)
A co-administered dose of Bemnifosbuvir (BEM)/Ruzasvir (RZR) as separate formulations and Biktarvy (BIK)
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
Québec, Montreal, Canada
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2024
First Posted
April 10, 2024
Study Start
April 15, 2024
Primary Completion
May 30, 2024
Study Completion
May 30, 2024
Last Updated
July 31, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share