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NCT Number: NCT07314346

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

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

Recruiting

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Key information

Conditions

Healthy Volunteer Study

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Atea Study Site, Hollywood, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Buprenorphine/Naloxone + BEM/RZR

Drug

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.

Other names: BEM (AT-527)/RZR (AT-038)

Methadone +BEM/RZR

Drug

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.

Other names: BEM (AT-527)/RZR (AT-038)

Primary outcomes

  1. Effect of BEM/RZR on PK of buprenorphine,norbuprenorphine and naloxone

    Time frame: Day -5 to Day 13

    Cmax

  2. Effect of BEM/RZR on PK of buprenorphine,norbuprenorphine and naloxone

    Time frame: Day -5 to Day 13

    AUC

  3. Effect of BEM/RZR on PK of methadone

    Time frame: Day -5 to Day 13

    Cmax

  4. Effect of BEM/RZR on PK of methadone

    Time frame: Day -5 to Day 13

    AUC

Study contacts

Contact information is provided by the study sponsor or research team.

Atea Study Clinical Trials Administrator

CONTACT

[email protected]

888-481-1607

Sponsors and collaborators

Lead sponsor

Atea Pharmaceuticals, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 2, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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