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
Atea Pharmaceuticals, Inc.
Summary
Drug-drug interaction study between Bemnifosbuvir/Ruzasvir (BEM/RZR) and Buprenorphine/Naloxone or Methadone
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- Yes
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 buprenorphi…
Interventions
- DrugBuprenorphine/Naloxone + BEM/RZR
Day -5 to Day -1:buprenorphine/naloxone as individualized QD doses up to 24mg/6mg. Day 1 to Day 5:Individualized QD doses of buprenorphine/naloxone. Day 6 to Day 12:Individualized QD doses of buprenorphine/naloxone + BEM 550mg/RZR 180mg QD. Day 13 Individualized QD doses of buprenorphine/naloxone.
- DrugMethadone +BEM/RZR
Day -5 to Day -1:methadone individualized QD doses: 30-150mg. Day 1 to Day 5:Individualized QD does of methadone. Day 6 to Day 12:Individualized QD doses of methadone + BEM 550mg/RZR 180mg QD. Day 13 Individualized QD doses of methadone.
Locations (3)
- Atea Study SiteHollywood, Florida
- Atea Study SiteOverland Park, Kansas
- Atea Study SiteMarlton, New Jersey