A Clinical Trial in Healthy Participants to Study the Effect of a Single Dose of MK-8527 on Levels of Methadone (MK-8527-020)

June 1, 2026 updated by: Merck Sharp & Dohme LLC

A Clinical Trial to Study the Effect of a Single Dose of MK-8527 on the Pharmacokinetics of Methadone

The goal of this study is to learn about the effect of a study medicine called MK-8527 when taken with methadone. The study will also measure what happens to the methadone in a healthy person's body over time after MK-8527 is taken.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

14

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Recruiting
        • Pinnacle Research Group ( Site 0002)
        • Contact:
          • Study Coordinator
          • Phone Number: 256-236-0055

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

  • Has a body-mass index (BMI) between 18 and 35 kg/m^2

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

  • Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
  • Has a history of cancer (malignancy)
  • Has a history of significant multiple and/or severe allergies (e.g., food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability (i.e., systemic allergic reaction) to prescription or nonprescription drugs or food
  • Has a positive test(s) for Hepatitis B surface antigen (HBsAg), hepatitis C antibodies or human immunodeficiency virus (HIV)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Methadone + MK-8527
Participants will receive methadone and MK-8527.
Drug: MK-8527
Tablet for oral administration.
Drug: Methadone
Formulated per local guidelines, administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
The dose-normalized AUC0-24hr of R-methadone will be determined on Day 1.
Up to 24 hours
Dose-Normalized AUC0-24 of S-Methadone
Time Frame: Up to 24 hours
The dose-normalized AUC0-24hr of S-methadone will be determined on Day 1.
Up to 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose-Normalized Maximum Plasma Concentration (Cmax) of R-Methadone
Time Frame: Up to approximately 2 weeks
The dose-normalized Cmax of R-methadone will be determined on Day 1.
Up to approximately 2 weeks
Dose-Normalized Cmax of S-Methadone
Time Frame: Up to approximately 2 weeks
The dose-normalized Cmax of S-methadone will be determined on Day 1.
Up to approximately 2 weeks
Dose-Normalized Plasma Concentration 24 Hours Postdose (C24) of R-Methadone
Time Frame: Up to 24 hours
The dose normalized C24hr of R-methadone will be determined on Day 1.
Up to 24 hours
Dose-Normalized C24 of S-Methadone
Time Frame: Up to 24 hours
The dose-normalized C24hr of S-methadone will be determined on Day 1.
Up to 24 hours
Number of Participants Who Experience an Adverse Event (AE)
Time Frame: Up to approximately 6 weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.
Up to approximately 6 weeks
Number of Participants Who Discontinue Study Treatment Due to an AE
Time Frame: Up to approximately 4 weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported.
Up to approximately 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharpe & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 22, 2026

Primary Completion (Estimated)

August 10, 2026

Study Completion (Estimated)

August 10, 2026

Study Registration Dates

First Submitted

April 7, 2026

First Submitted That Met QC Criteria

April 7, 2026

First Posted (Actual)

April 14, 2026

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8527-020
  • MK-8527-020 (Other Identifier: MSD)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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