RecruitingPhase 1NCT07314346

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

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

Sponsor

Atea Pharmaceuticals, Inc.

Enrollment

32 participants

Start Date

Jan 7, 2025

Study Type

INTERVENTIONAL

Conditions

Healthy Volunteer Study

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria3

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 Criteria5

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.

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Interventions

DRUGBuprenorphine/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.

DRUGMethadone +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.