A Clinical Trial to Compare Forms of MK-1167 in Healthy People (MK-1167-011)

March 17, 2026 updated by: Merck Sharp & Dohme LLC

A Two-Period, Open-label, Fixed-Sequence Study to Evaluate the Single-Dose Pharmacokinetics of Two Formulations of MK-1167 in Healthy Participants

Researchers are looking for new ways to treat Alzheimer's disease (AD). AD is a brain disease that causes a gradual decline in memory, thinking, and ability to carry out daily tasks. MK-1167 is a study medicine designed to treat symptoms of AD. Before giving a study medicine to people with a health condition, researchers first do studies in healthy people to find a safe dose of the study medicine.

The goals of the trial are to learn:

  • What happens to different forms of MK-1167 in a healthy person's body over time
  • About the safety of MK-1167 and if people tolerate it

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • South Miami, Florida, United States, 33143
        • QPS-MRA, LLC ( Site 0001)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Is in good health
  • Has a body mass index (BMI) ≥18 and ≤ 32 kg/m^2, inclusive

Exclusion Criteria:

  • Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological abnormalities or diseases
  • Is a smoker and/or has used nicotine or nicotine-containing products within the past 3 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1: MK-1167 Form 2
Participants receive MK-1167 Form 2 orally.
Drug: MK-1167
Oral administration
Experimental: Arm 2: MK-1167 Form 1
Participants receive MK-1167 Form 1 orally.
Drug: MK-1167
Oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area Under the Curve from Time 0 to Infinity (AUC0-inf) of MK-1167
Time Frame: At designated time points (up to approximately 21 days)
Blood samples will be collected to determine the AUC0-inf of MK-1167.
At designated time points (up to approximately 21 days)
Maximum Plasma Concentration (Cmax) of MK-1167
Time Frame: At designated time points (up to approximately 21 days)
Blood samples will be collected to determine the Cmax of MK-1167.
At designated time points (up to approximately 21 days)
Area Under the Curve from Time 0 to Last Measurable Concentration (AUC0-last) of MK-1167
Time Frame: At designated time points (up to approximately 21 days)
Blood samples will be collected to determine the AUC0-last of MK-1167.
At designated time points (up to approximately 21 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area Under the Curve from Time 0 to 24 hours (AUC0-24) of MK-1167
Time Frame: At designated time points (up to approximately 24 hours)
Blood samples will be collected to determine the AUC0-24 of MK-1167.
At designated time points (up to approximately 24 hours)
Concentration at 24 hours (C24) of MK-1167
Time Frame: At designated time points (up to approximately 24 hours)
Blood samples will be collected to determine the C24 of MK-1167.
At designated time points (up to approximately 24 hours)
Time to Maximum Serum Concentration (Tmax) of MK-1167
Time Frame: At designated time points (up to approximately 21 days)
Blood samples will be collected to determine the Tmax of MK-1167.
At designated time points (up to approximately 21 days)
Apparent Terminal Half-life (t1/2) of MK-1167
Time Frame: At designated time points (up to approximately 21 days)
Blood samples will be collected to determine the t1/2 of MK-1167.
At designated time points (up to approximately 21 days)
Apparent Clearance after Nonintravenous Administration (CL/F) of MK-1167
Time Frame: At designated time points (up to approximately 21 days)
Blood samples will be collected to determine the CL/F of MK-1167.
At designated time points (up to approximately 21 days)
Apparent Volume of Distribution during Terminal Phase (Vz/F) of MK-1167
Time Frame: At designated time points (up to approximately 21 days)
Blood samples will be collected to determine the Vz/F of MK-1167.
At designated time points (up to approximately 21 days)
Number of Participants Who Experience One or More Adverse Events (AEs)
Time Frame: Up to approximately 78 days
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.
Up to approximately 78 days
Number of Participants Who Discontinue Study Intervention Due to an AE
Time Frame: Up to approximately 36 days
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be reported.
Up to approximately 36 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2026

Primary Completion (Estimated)

May 28, 2026

Study Completion (Estimated)

May 28, 2026

Study Registration Dates

First Submitted

December 31, 2025

First Submitted That Met QC Criteria

December 31, 2025

First Posted (Actual)

January 12, 2026

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 1167-011
  • MK-1167-011 (Other Identifier: MSD)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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