Actively Recruiting

Phase 1
Age: 18Years - 65Years
All Genders
Healthy Volunteers
ID07528508

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

Led by Merck Sharp & Dohme LLC · Updated on 2026-06-02

14

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to explore the effects of a study drug called MK-8527 when taken together with methadone in healthy adult volunteers. The study focuses on understanding how methadone behaves in the body over time after taking MK-8527, providing important information about the interaction between these two drugs. The trial is a Phase 1 clinical trial sponsored by Merck Sharp & Dohme LLC and includes healthy participants aged 18 to 65 years with specific health criteria. Participants will receive both methadone and MK-8527 orally as part of the experimental treatment. The study measures how the body processes methadone over a 24-hour period after dosing, analyzing specific levels of methadone in the blood. The trial does not include a placebo group and involves careful monitoring of drug concentrations and participant safety during and after treatment. During the study, participants will undergo blood tests to measure methadone levels and observe any side effects or adverse events for up to six weeks. Researchers will track the maximum concentration of methadone, its presence in the blood at various times, and any reactions that might cause participants to stop treatment. The entire study duration and follow-up provide a detailed understanding of drug interactions and participant safety.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 65 years
  • Body-mass index (BMI) between 18 and 35 kg/m²
  • Healthy adult volunteers
Not Eligible

You will not qualify if you...

  • History of significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological diseases
  • History of cancer (malignancy)
  • History of severe allergies or systemic allergic reactions to drugs, food, or latex
  • Positive tests for Hepatitis B surface antigen, hepatitis C antibodies, or HIV infection

AI-Screening

AI-Powered Screening

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Your Study Journey: What to Expect

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 24 hours

Participants receive a single dose of MK-8527 along with methadone.

1 treatment visit (in-person) with monitoring for up to 24 hours

Follow-up

Duration - Up to approximately 6 weeks

Participants are monitored for safety and adverse events after treatment.

Several follow-up visits during the monitoring period

Trial Site Locations

Total: 1 location

1

Pinnacle Research Group ( Site 0002)

Anniston, Alabama, United States, 36207

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Research Team

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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