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

ConditionHealthy Volunteer Study
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAtea Pharmaceuticals, Inc.

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: (n=16) buprenorphine/naloxone + BEM/RZRExperimental treatment 1 intervention
Group B: (n=16) methadone + BEM/RZRExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Cmax

Time frame
Day -5 to Day 13
2

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

AUC

Time frame
Day -5 to Day 13
3

Effect of BEM/RZR on PK of methadone

Cmax

Time frame
Day -5 to Day 13
4

Effect of BEM/RZR on PK of methadone

AUC

Time frame
Day -5 to Day 13

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Atea Pharmaceuticals, Inc.

Lead sponsor

Source ClinicalTrials.gov
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