Drug-drug Interaction Study of Bemnifosbuvir/Ruzasvir (BEM/RZR) and Digoxin and Rosuvastatin
A Phase 1, Open-Label, Two-Part Study to Evaluate the Effect of a Single Oral Dose of Bemnifosbuvir/Ruzasvir Fixed Dose Combination on the Pharmacokinetics of Digoxin and Rosuvastatin in Healthy Subjects
1 other identifier
interventional
38
1 country
1
Brief Summary
Drug-drug interaction study between Bemnifosbuvir/Ruzasvir and Digoxin or Rosuvastatin
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 Apr 2025
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
March 27, 2025
CompletedStudy Start
First participant enrolled
April 8, 2025
CompletedFirst Posted
Study publicly available on registry
April 10, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 2, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 2, 2025
CompletedAugust 29, 2025
August 1, 2025
3 months
March 27, 2025
August 25, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
PK of Digoxin and Rosuvastatin (Cmax)
Digoxin: Days 1,15, 29; Rosuvastatin: Days 1, 8, 15
PK of Digoxin and Rosuvastatin (AUC)
Digoxin: Days 1,15, 29; Rosuvastatin: Days 1, 8, 15
Study Arms (2)
Digoxin vs Digoxin + BEM/RZR vs Digoxin + 2h BEM/RZR
EXPERIMENTALRosuvastatin vs Rosuvastatin + BEM/RZR vs Rosuvastatin + 2h BEM/RZR
EXPERIMENTALInterventions
Treatment-A (Digoxin): A single dose of digoxin will be administered under fasting conditions. Treatment-B (Digoxin + BEM/RZR): A single dose of digoxin will be co-administered a single dose of BEM/RZR under fasting conditions. Treatment-C (Digoxin + 2h BEM/RZR): A single dose of digoxin will be administered under fasting conditions. Then, a single dose of BEM/RZR will be administered approximately 2 hours later under fasting conditions.
Treatment-D (rosuvastatin): A single dose of rosuvastatin will be administered under fasting conditions. Treatment-E (rosuvastatin + BEM/RZR): A single dose of rosuvastatin will be co-administered with a single dose BEM/RZR under fasting conditions. Treatment-F (rosuvastatin + 2h BEM/RZR): A single dose of rosuvastatin will be administered under fasting conditions. Then, a single dose BEM/RZR will be administered approximately 2 hours later under fasting conditions.
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
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2025
First Posted
April 10, 2025
Study Start
April 8, 2025
Primary Completion
July 2, 2025
Study Completion
July 2, 2025
Last Updated
August 29, 2025
Record last verified: 2025-08