Menu
Recruiting NCT07314346

Drug-drug Interaction Study of Bemnifosbuvir/Ruzasvir (BEM/RZR) and Buprenorphine/Naloxone or Methadone

Phase I Interventional Healthy Volunteer Study

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Buprenorphine/Naloxone + BEM/RZR, Methadone +BEM/RZR.
Who it may be relevant to
Registry conditions: Healthy Volunteer Study. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

Interventions

  • 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.

Primary outcome measures

  • Effect of BEM/RZR on PK of buprenorphine,norbuprenorphine and naloxone [Time frame: Day -5 to Day 13]
  • Effect of BEM/RZR on PK of buprenorphine,norbuprenorphine and naloxone [Time frame: Day -5 to Day 13]
  • Effect of BEM/RZR on PK of methadone [Time frame: Day -5 to Day 13]
  • Effect of BEM/RZR on PK of methadone [Time frame: Day -5 to Day 13]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 3 centers
  • Atea Study Site — Hollywood
  • Atea Study Site — Overland Park
  • Atea Study Site — Marlton

Identifiers

NCT: NCT07314346 · AT-01B-013

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗