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

NCT07528508 | Completed Phase 1 FDA Drug

• 2 other identifiers: 8527-020MK-8527-020
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Dose-Normalized Area Under the Plasma Concentration Time Curve From 0-24 Hours Postdose (AUC0-24) of R-Methadone

  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

  The dose-normalized AUC0-24hr of S-methadone will be determined on Day 1.

  Up to 24 hours

Secondary Outcomes (6)

• Dose-Normalized Maximum Plasma Concentration (Cmax) of R-Methadone

  Up to approximately 2 weeks

• Dose-Normalized Cmax of S-Methadone

  Up to approximately 2 weeks

• Dose-Normalized Plasma Concentration 24 Hours Postdose (C24) of R-Methadone

  Up to 24 hours

• Dose-Normalized C24 of S-Methadone

  Up to 24 hours

• Number of Participants Who Experience an Adverse Event (AE)

  Up to approximately 6 weeks

Study Arms (1)

Methadone + MK-8527

EXPERIMENTAL

Participants will receive methadone and MK-8527.

Drug: MK-8527; Drug: Methadone

Interventions

MK-8527 DRUG

Tablet for oral administration.

Methadone + MK-8527

Methadone DRUG

Formulated per local guidelines, administered orally.

Methadone + MK-8527

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

Pinnacle Research Group ( Site 0002)

Anniston, Alabama, 36207, United States

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Interventions

Methadone

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals

Study Officials

• Medical Director

  Merck Sharpe & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 14, 2026
• Study Start: May 22, 2026
• Primary Completion: July 31, 2026
• Study Completion: July 31, 2026
• Last Updated: August 26, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)