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

Part of paid clinical trials in Hollywood, Florida.

Sponsor
Atea Pharmaceuticals, Inc.
Study ID
NCT07314346
Phase
PHASE1
Status
Recruiting
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Conditions

  • Healthy Volunteer Study

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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

Key Dates

Start date
Jan 7, 2025
Status verified
Dec 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
32 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: (n=16) buprenorphine/naloxone + BEM/RZR
  • Experimental: (n=16) methadone + BEM/RZR

Primary Outcome Measure

Effect of BEM/RZR on PK of buprenorphine,norbuprenorphine and naloxone [ Time Frame: Day -5 to Day 13 ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Atea Study SiteHollywoodFlorida33019
Atea Study Clinical Trials Administrator
[email protected]
888-481-1607
Atea Study SiteOverland ParkKansas66212
Atea Study Clinical Trials Administrator
[email protected]
888-481-1607
Atea Study SiteMarltonNew Jersey08053
Atea Study Clinical Trials Administrator
[email protected]
888-481-1607

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Atea Study Site· Hollywood, FLAtea Study Site· Overland Park, KSAtea Study Site· Marlton, NJ

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