Drug-drug Interaction Study of Bemnifosbuvir/Ruzasvir (BEM/RZR) and Buprenorphine/Naloxone or Methadone
NCT ID: NCT07314346
Last Updated: 2026-01-02
Study Results
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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NOT_YET_RECRUITING
PHASE1
32 participants
INTERVENTIONAL
2025-12-31
2026-05-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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(n=16) buprenorphine/naloxone + BEM/RZR
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.
(n=16) methadone + BEM/RZR
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.
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
Yes
Sponsors
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Atea Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Atea Study Site
Overland Park, Kansas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AT-01B-013
Identifier Type: -
Identifier Source: org_study_id
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