Drug-drug Interaction Study of Bemnifosbuvir/Ruzasvir (BEM/RZR) and Digoxin and Rosuvastatin
NCT ID: NCT06921941
Last Updated: 2025-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
38 participants
INTERVENTIONAL
2025-04-08
2025-07-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Digoxin vs Digoxin + BEM/RZR vs Digoxin + 2h BEM/RZR
Digoxin vs Digoxin + BEM/RZR vs Digoxin + 2h BEM/RZR
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.
Rosuvastatin vs Rosuvastatin + BEM/RZR vs Rosuvastatin + 2h BEM/RZR
Rosuvastatin vs Rosuvastatin + BEM/RZR vs Rosuvastatin + 2h BEM/RZR
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.
Interventions
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Digoxin vs Digoxin + BEM/RZR vs Digoxin + 2h BEM/RZR
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.
Rosuvastatin vs Rosuvastatin + BEM/RZR vs Rosuvastatin + 2h BEM/RZR
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
55 Years
ALL
Yes
Sponsors
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Atea Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Atea Study Site
Québec, Montreal, Canada
Countries
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Other Identifiers
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AT-01B-009
Identifier Type: -
Identifier Source: org_study_id
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