Recruiting
Phase 1

Ulonivirine with Methadone

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT07595263

Conditions

Healthy

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Ulonivirine

Methadone

Study Details

Brief summary:

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.

Conditions

Healthy

Study ID

NCT07595263

Start date

Aug 17, 2026

Status verified date

Sep, 2026

Completion date

Jan 15, 2027

Anticipated

Primary completion date

Jan 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Inclusion Criteria

The main Inclusion Criteria include but are not limited to:

  • Is in good health
  • Has a body mass index (BMI) between >18 and ≤40 kg/m\^2
  • Is reliably participating in a methadone maintenance program for at least 2 months prior to Day 1 and is on a documented stable dose of methadone for at least 14 days prior to Day 1

Exclusion Criteria

The main Exclusion Criteria include but are not limited to:

  • Has a history of cancer (malignancy)
  • Has a history of significant multiple and/or severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription drugs or food
  • Has tested positive human immunodeficiency virus (HIV) or for a sexually transmitted infection at screening
  • Is under the age of legal consent

Study Design

Enrollment

14 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

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.

Interventions

Ulonivirine

Oral Tablet

Methadone

Oral (per local guidelines)

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 ]
  • Dose-Normalized AUC0-24 of S-Methadone [ Time Frame: Up to 24 hours post-dose ]

Central Contacts and Locations

Central contacts

Toll Free Number

1-888-577-8839Trialsites@msd.com

Locations

Pinnacle Research Group ( Site 0002)

Recruiting

Anniston, Alabama, United States, 36207

Contacts

Study Coordinator

256-236-0055

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Sep 23, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-09-23. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.