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Digoxin vs Digoxin+ BEM/RZR vs Digoxin+ 2h BEM/RZR

Phase 1

Healthy Volunteer Study | Small molecule | Other |Atea Pharmaceuticals, Inc.|Last Updated: Aug 29, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment38

FDA Designations

No designations recorded

Clinical trial landscape

Digoxin vs Digoxin+ BEM/RZR vs Digoxin+ 2h BEM/RZR · 1 trial · 1 indication

Phase 1 1
NCT06921941Drug-drug Interaction Study of Bemnifosbuvir/Ruzasvir (BEM/RZR) and Digoxin and RosuvastatinHealthy Volunteer Study
COMPLETED38 Analytics
PHASE1COMPLETED
Drug-drug Interaction Study of Bemnifosbuvir/Ruzasvir (BEM/RZR) and Digoxin and Rosuvastatin
Healthy Volunteer StudyUnlock trial analytics

Study Endpoints

Primary Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Digoxin vs Digoxin + BEM/RZR vs Digoxin + 2h BEM/RZREXPERIMENTAL -
Rosuvastatin vs Rosuvastatin + BEM/RZR vs Rosuvastatin + 2h BEM/RZREXPERIMENTAL -

Interventions

NameTypeDescription
Digoxin vs Digoxin + BEM/RZR vs Digoxin + 2h BEM/RZRDRUGTreatment-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/RZRDRUGTreatment-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.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

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/m2. * Willing to comply with the study requirements and to provide written in...

Countries:Canada
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