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Digoxin vs Digoxin+ BEM/RZR vs Digoxin+ 2h BEM/RZR · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Digoxin vs Digoxin + BEM/RZR vs Digoxin + 2h BEM/RZR | EXPERIMENTAL | - |
| Rosuvastatin vs Rosuvastatin + BEM/RZR vs Rosuvastatin + 2h BEM/RZR | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Digoxin vs Digoxin + BEM/RZR vs Digoxin + 2h BEM/RZR | DRUG | 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 | DRUG | 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. |
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...
Digoxin vs Digoxin + BEM/RZR vs Digoxin + 2h BEM/RZR refers to the treatment arms of a Phase 1 drug-drug interaction study evaluating whether bemnifosbuvir/ruzasvir (BEM/RZR) affects digoxin exposure. The study compared digoxin alone, digoxin given with BEM/RZR, and digoxin given two hours after BEM/RZR in healthy volunteers.
The study involves digoxin, which inhibits the ATP1A1, ATP1B2, ATP1B1, ATP1A2, ATP1B3, and ATP1A3 sodium-potassium ATPase subunits, and bemnifosbuvir/ruzasvir, an investigational antiviral combination. The trial assessed whether coadministration of BEM/RZR alters digoxin pharmacokinetics, a transporter-mediated interaction relevant to the ATP1A1 target class.
Atea Pharmaceuticals, Inc. (ticker AVIR) is the developer of the bemnifosbuvir/ruzasvir combination evaluated in this drug-drug interaction study. Digoxin itself is a widely used marketed cardiac glycoside; Atea sponsored the Phase 1 trial that tested digoxin alone and with BEM/RZR.
This is a Phase 1 drug-drug interaction study. The single trial, NCT06921941, is completed and enrolled 38 healthy adult volunteers in Canada. The study was randomized and controlled but not double-blind, and it was not biomarker-selected.
One trial is registered: NCT06921941, titled Drug-drug Interaction Study of Bemnifosbuvir/Ruzasvir (BEM/RZR) and Digoxin and Rosuvastatin. It is a completed Phase 1 study with 38 enrolled healthy volunteers, ages 18 and older, of all sexes, conducted in Canada.