A Study of Ulonivirine (MK-8507) and Methadone in Healthy Volunteers (MK-8507-019)

Part of paid clinical trials in Anniston, Alabama.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT07595263
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Ulonivirine — DRUG
    Oral Tablet
  • Methadone — DRUG
    Oral (per local guidelines)

Study Details

This study is designed to determine the effect of ulonivirine (MK-8507) on methadone in the body. Participants will take methadone alone and then methadone with ulonivirine to see if ulonivirine changes how the body processes methadone.

Key Dates

First listed
May 19, 2026
Start date
Aug 17, 2026
Status verified
Aug 2026
Primary completion
Jan 15, 2027
Completion
Jan 15, 2027

Study Design

Enrollment
14 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Methadone + Ulonivirine
    Participants receive a stable dose of methadone orally from Day -14 through Day 16. Methadone is co-administered with one dose of oral ulonivirine on Day 2.

Primary Outcome Measure

Dose-Normalized Area Under the Plasma Concentration Time Curve From 0-24 Hours Postdose (AUC0-24) of R-Methadone [ Time Frame: Up to 24 hours post-dose ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Pinnacle Research Group ( Site 0002)AnnistonAlabama36207
Study Coordinator
256-236-0055

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By research site
Pinnacle Research Group· Anniston, AL

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