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

NCT ID: NCT07314346

Last Updated: 2026-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2026-05-29

Brief Summary

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

Detailed Description

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Conditions

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Healthy Volunteer Study

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

Group Type EXPERIMENTAL

Buprenorphine/Naloxone + BEM/RZR

Intervention Type 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.

(n=16) methadone + BEM/RZR

Group Type EXPERIMENTAL

Methadone +BEM/RZR

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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BEM (AT-527)/RZR (AT-038) BEM (AT-527)/RZR (AT-038)

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Atea Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Atea Study Site

Overland Park, Kansas, United States

Site Status

Countries

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United States

Central Contacts

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Atea Study Clinical Trials Administrator

Role: CONTACT

888-481-1607

Facility Contacts

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Atea Study Clinical Trials Administrator

Role: primary

888-481-1607

Other Identifiers

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AT-01B-013

Identifier Type: -

Identifier Source: org_study_id

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