Healthy
Conditions
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.
Interventions
DRUGMK-8527
Tablet for oral administration.
DRUGMethadone
Formulated per local guidelines, administered orally.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose-Normalized Area Under the Plasma Concentration Time Curve From 0-24 Hours Postdose (AUC0-24) of R-Methadone | Up to 24 hours | The dose-normalized AUC0-24hr of R-methadone will be determined on Day 1. |
| Dose-Normalized AUC0-24 of S-Methadone | Up to 24 hours | The dose-normalized AUC0-24hr of S-methadone will be determined on Day 1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dose-Normalized Maximum Plasma Concentration (Cmax) of R-Methadone | Up to approximately 2 weeks | The dose-normalized Cmax of R-methadone will be determined on Day 1. |
| Dose-Normalized Cmax of S-Methadone | Up to approximately 2 weeks | The dose-normalized Cmax of S-methadone will be determined on Day 1. |
| Dose-Normalized Plasma Concentration 24 Hours Postdose (C24) of R-Methadone | Up to 24 hours | The dose normalized C24hr of R-methadone will be determined on Day 1. |
| Dose-Normalized C24 of S-Methadone | Up to 24 hours | The dose-normalized C24hr of S-methadone will be determined on Day 1. |
| Number of Participants Who Experience an Adverse Event (AE) | 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. |
| Number of Participants Who Discontinue Study Treatment Due to an AE | 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. |
Contacts
STUDY_DIRECTORMedical Director
Merck Sharpe & Dohme LLC
Outcome results
None listed