A Clinical Trial in Healthy Participants to Study the Eff... | NCT07528508

Studies
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

Sponsor

Merck Sharp & Dohme LLC

Status

Recruiting

Last Update Posted

Jun 2, 2026Actual

Enrollment

14Estimated

Phase

Phase 1

Conditions

Healthy

Interventions

MK-8527
Methadone

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
MK-8527-020	Other Identifier	MSD

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 22, 2026Actual

Primary Completion Date

Aug 10, 2026Estimated

Completion Date

Aug 10, 2026Estimated

First Submitted Date

Apr 7, 2026

First Submission Date that Met QC Criteria

Apr 7, 2026

First Posted Date

Apr 14, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 1, 2026

Last Update Posted Date

Jun 2, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

14Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Methadone + MK-8527	Experimental	Participants will receive methadone and MK-8527.	Drug: MK-8527 Drug: Methadone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MK-8527	Drug	Tablet for oral administration.	Methadone + MK-8527
Methadone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Dose-Normalized Maximum Plasma Concentration (Cmax) of R-Methadone	The dose-normalized Cmax of R-methadone will be determined on Day 1.	Up to approximately 2 weeks
Dose-Normalized Cmax of S-Methadone

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Toll Free Number	Contact	1-888-577-8839		Trialsites@msd.com

Overall Officials

Name	Affiliation	Role
Medical Director	Merck Sharpe & Dohme LLC	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pinnacle Research Group ( Site 0002)	Recruiting	Anniston	Alabama	36207	United States

Label	URL
Merck Clinical Trials Information	View source

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

https://externaldatasharing-msd.com/

ID	Term
D007659	Ketones
D009930	Organic Chemicals