Recruiting
Phase 1

BEM/RZR & Buprenorphine

Sponsor:

Atea Pharmaceuticals, Inc.

Code:

NCT07314346

Conditions

Healthy Volunteer Study

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Buprenorphine/Naloxone + BEM/RZR

Methadone +BEM/RZR

Study Details

Brief summary:

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

Conditions

Healthy Volunteer Study

Study ID

NCT07314346

Start date

Jan 7, 2025

Status verified date

Dec, 2025

Completion date

Aug, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

32 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: (n=16) buprenorphine/naloxone + BEM/RZR

experimental: (n=16) methadone + BEM/RZR

Interventions

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.

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 measure

  • 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 ]

Central Contacts and Locations

Central contacts

Atea Study Clinical Trials Administrator

888-481-1607ateaclinicaltrials@ateapharma.com

Locations

Atea Study Site

Recruiting

Hollywood, Florida, United States, 33019

Contacts

Atea Study Clinical Trials Administrator

888-481-1607ateaclinicaltrials@ateapharma.com

Atea Study Site

Recruiting

Overland Park, Kansas, United States, 66212

Contacts

Atea Study Clinical Trials Administrator

888-481-1607ateaclinicaltrials@ateapharma.com

Atea Study Site

Recruiting

Marlton, New Jersey, United States, 08053

Contacts

Atea Study Clinical Trials Administrator

888-481-1607ateaclinicaltrials@ateapharma.com

More Information

Sponsor

Atea Pharmaceuticals, Inc.

Last update posted

Jul 16, 2026

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Atea Pharmaceuticals, Inc. on 2026-07-16.