NCT07314346

Drug-drug Interaction Study of Bemnifosbuvir/Ruzasvir (BEM/RZR) and 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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Atea Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Drug-drug interaction study between Bemnifosbuvir/Ruzasvir (BEM/RZR) and Buprenorphine/Naloxone or Methadone

Conditions

• Healthy Volunteer Study

Interventions

Type	Name	Description
DRUG	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.
DRUG	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.

Timeline

• Start date: 2025-01-07
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2026-01-02
• Last updated: 2026-04-13

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study