Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years
- Body-mass index (BMI) between 18 and 35 kg/m²
- Healthy adult volunteers
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
Complete this quick 3-step screening to check your eligibility
Your Study Journey: What to Expect
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Actively Recruiting
Research Team
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Toll Free Number
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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