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

Merck Sharp & Dohme LLC14 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

MK-8527DRUG

Tablet for oral administration.

MethadoneDRUG

Formulated per local guidelines, administered orally.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Pinnacle Research Group ( Site 0002)

Anniston, Alabama, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Up to 24 hours

Secondary Outcomes

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

The dose-normalized Cmax of R-methadone will be determined on Day 1.

Time frame: Up to approximately 2 weeks

Dose-Normalized Cmax of S-Methadone

The dose-normalized Cmax of S-methadone will be determined on Day 1.

Time frame: Up to approximately 2 weeks

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

The dose normalized C24hr of R-methadone will be determined on Day 1.

Time frame: Up to 24 hours

Dose-Normalized C24 of S-Methadone

The dose-normalized C24hr of S-methadone will be determined on Day 1.

Time frame: Up to 24 hours

Number of Participants Who Experience an Adverse Event (AE)

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.

Time frame: Up to approximately 6 weeks

Data from ClinicalTrials.gov

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