Study of how Bemnifosbuvir/Ruzasvir interacts with 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
This study tests how the new drug Bemnifosbuvir/Ruzasvir interacts with the common medications Digoxin and Rosuvastatin to see if it's safe to use them together.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Atea Pharmaceuticals, Inc. Industry-sponsored |
| Locations | 1 site (Québec, Montreal) |
| Trial ID | NCT06921941 on ClinicalTrials.gov |
What this trial studies
This study investigates the drug-drug interactions between Bemnifosbuvir/Ruzasvir (BEM/RZR) and two commonly used medications, Digoxin and Rosuvastatin. Healthy volunteers will be administered these drugs in various combinations to assess how BEM/RZR affects their pharmacokinetics. The study aims to ensure the safety and efficacy of BEM/RZR when used alongside these medications. Participants will be closely monitored for any adverse effects or changes in drug metabolism.
Who should consider this trial
Good fit: Ideal candidates are healthy volunteers aged 18-65 with a BMI between 18-30 and a body weight of at least 50 kg.
Not a fit: Patients with active infections, substance abuse issues, or those taking other medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical information on the safe use of Bemnifosbuvir/Ruzasvir in patients taking Digoxin or Rosuvastatin.
How similar studies have performed: While this specific combination has not been extensively tested, drug-drug interaction studies are common and have shown success in understanding medication safety.
Eligibility criteria
Show full inclusion / exclusion criteria
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 informed consent. Exclusion Criteria: * 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.
Where this trial is running
Québec, Montreal
- Atea Study Site — Québec, Montreal, Canada (Recruiting)
Study contacts
- Study coordinator: Atea Study Clinical Trials Administrator
- Email: ateaclinicaltrials@ateapharma.com
- Phone: 888-481-1607
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.