Buprenorphine/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.
Methadone +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.
Study summary
Drug-drug interaction study between Bemnifosbuvir/Ruzasvir (BEM/RZR) and Buprenorphine/Naloxone or Methadone
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
Effect of BEM/RZR on PK of buprenorphine,norbuprenorphine and naloxone — Day -5 to Day 13 Cmax
Effect of BEM/RZR on PK of buprenorphine,norbuprenorphine and naloxone — Day -5 to Day 13 AUC
Effect of BEM/RZR on PK of methadone — Day -5 to Day 13 Cmax
Effect of BEM/RZR on PK of methadone — Day -5 to Day 13 AUC
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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