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
1 other identifier
interventional
32
1 country
3
Brief Summary
Drug-drug interaction study between Bemnifosbuvir/Ruzasvir (BEM/RZR) and Buprenorphine/Naloxone or Methadone
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jan 2025
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 7, 2025
CompletedFirst Submitted
Initial submission to the registry
December 18, 2025
CompletedFirst Posted
Study publicly available on registry
January 2, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
April 13, 2026
December 1, 2025
1.4 years
December 18, 2025
April 8, 2026
Conditions
Outcome Measures
Primary Outcomes (4)
Effect of BEM/RZR on PK of buprenorphine,norbuprenorphine and naloxone
Cmax
Day -5 to Day 13
Effect of BEM/RZR on PK of buprenorphine,norbuprenorphine and naloxone
AUC
Day -5 to Day 13
Effect of BEM/RZR on PK of methadone
Cmax
Day -5 to Day 13
Effect of BEM/RZR on PK of methadone
AUC
Day -5 to Day 13
Study Arms (2)
(n=16) buprenorphine/naloxone + BEM/RZR
EXPERIMENTAL(n=16) methadone + BEM/RZR
EXPERIMENTALInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Atea Study Site
Hollywood, Florida, 33019, United States
Atea Study Site
Overland Park, Kansas, 66212, United States
Atea Study Site
Marlton, New Jersey, 08053, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2025
First Posted
January 2, 2026
Study Start
January 7, 2025
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
April 13, 2026
Record last verified: 2025-12