Bemnifosbuvir/ruzasvir interaction with buprenorphine/naloxone or methadone
A Phase 1, Open-Label, Two-Part, Single-Sequence Study to Evaluate the Effect of Multiple Oral Doses of BEM/RZR FDC on the Pharmacokinetics of Buprenorphine/Naloxone or Methadone in Participants on Stable Maintenance Therapy for Opiate Withdrawal
This trial will see if taking bemnifosbuvir/ruzasvir changes how buprenorphine/naloxone or methadone is processed in healthy adults.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Atea Pharmaceuticals, Inc. Industry-sponsored |
| Locations | 3 sites (Hollywood, Florida and 2 other locations) |
| Trial ID | NCT07314346 on ClinicalTrials.gov |
What this trial studies
This Phase 1 interventional study tests drug-drug interactions between the antiviral combination bemnifosbuvir/ruzasvir and the opioid maintenance therapies buprenorphine/naloxone or methadone in healthy volunteers. Participants will receive controlled dosing and undergo serial blood sampling to measure drug levels and monitor safety and tolerability. Key eligibility requirements include minimum weight and BMI limits, negative tests for hepatitis B, hepatitis C, and HIV, no substance-abuse issues, and agreement to use contraception for the specified period. The study is sponsored by Atea Pharmaceuticals and is conducted at three U.S. sites in Florida, Kansas, and New Jersey.
Who should consider this trial
Good fit: Ideal candidates are healthy adults who meet the weight and BMI criteria, are free of hepatitis B/C and HIV, do not have current substance-abuse issues, agree to contraceptive requirements, and can attend one of the study sites.
Not a fit: People with active hepatitis B or C, HIV infection, ongoing substance abuse, those taking other prescription or systemic medications, or those unable to travel to a study site are unlikely to qualify or benefit from this trial.
Why it matters
Potential benefit: If successful, the results could tell clinicians whether bemnifosbuvir/ruzasvir can be given safely with buprenorphine/naloxone or methadone and whether dose adjustments are needed.
How similar studies have performed: Other drug–drug interaction studies between antivirals and opioid maintenance therapies have been performed and have sometimes found clinically important changes in drug levels that informed dosing guidance.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Must agree to use acceptable contraceptive methods through at least 90 days after the last dose of study drug. * Minimum body weight of 50 kg and body mass index (BMI) of 18-32 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. * Abuse of alcohol or drugs. * Use of other investigational drugs within 28 days prior to Day -5. * Concomitant use of prescription medications, or systemic over-the-counter medications (apart from methadone or buprenorphine/naloxone as assigned maintenance therapy). * Other clinically significant medical conditions or laboratory abnormalities.
Where this trial is running
Hollywood, Florida and 2 other locations
- Atea Study Site — Hollywood, Florida, United States (Recruiting)
- Atea Study Site — Overland Park, Kansas, United States (Recruiting)
- Atea Study Site — Marlton, New Jersey, United States (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.