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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07314346

Enrollment

Registered

2026-01-02

Start date

2025-01-07

Completion date

2026-08-01

Last updated

2026-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer Study

Brief summary

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

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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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 buprenorphine/naloxone as assigned maintenance therapy). * Other clinically significant medical conditions or laboratory abnormalities.

Design outcomes

Primary

Measure	Time frame	Description
Effect of BEM/RZR on PK of buprenorphine,norbuprenorphine and naloxone	Day -5 to Day 13	Cmax
Effect of BEM/RZR on PK of methadone	Day -5 to Day 13	Cmax

Countries

United States

Contacts

CONTACTAtea Study Clinical Trials Administrator

ateaclinicaltrials@ateapharma.com888-481-1607

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 17, 2026