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Drug-drug Interaction Study of Bemnifosbuvir/Ruzasvir (BEM/RZR) and Buprenorphine/Naloxone or Methadone
Sponsor: Atea Pharmaceuticals, Inc.
Summary
Drug-drug interaction study between Bemnifosbuvir/Ruzasvir (BEM/RZR) and Buprenorphine/Naloxone or Methadone
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
32
Start Date
2025-12
Completion Date
2026-05-29
Last Updated
2026-01-02
Healthy Volunteers
Yes
Conditions
Interventions
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.
Locations (1)
Atea Study Site
Overland Park, Kansas, United States