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Completed

NCT Number: NCT07528508

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

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.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pinnacle Research Group ( Site 0002)

Anniston, Alabama, 36207, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

MK-8527

Drug

Tablet for oral administration.

Methadone

Drug

Formulated per local guidelines, administered orally.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 14, 2026
Registry last updated
Aug 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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