A Clinical Trial of MK-1403 in Healthy Participants (MK-1403-007)
September 15, 2026 updated by: Merck Sharp & Dohme LLC
A Clinical Study to Evaluate the Relative Bioavailability of MK-1403 Formulations Administered to Healthy Adult Participants
The purpose of this trial is to learn about a trial medicine called MK-1403. Researchers designed MK-1403 to treat a type of heart and blood vessel disease called atherosclerotic cardiovascular disease (ASCVD).
Before giving a trial medicine to people with a health condition, researchers first do clinical trials in healthy people. This trial will help researchers learn about the safety of MK-1403 and if participants tolerate it. Tolerate means participants receive the trial medicine and they do not need to stop taking it due to health problems. The trial will also measure what happens to MK 1403 in a healthy person's body over time.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
15
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
-
-
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
Exclusion Criteria:
- Has history of cancer (malignancy)
- Has a history of significant multiple and/or severe allergies
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: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: MK-1403 formulation (FM) 1 + additive, Fed
MK-1403 FM 1 + additive tablet administered once orally at study dose after a high-fat meal.
|
Oral tablet
|
|
Experimental: MK-1403 FM1 + additive, Fasted
MK-1403 FM1 + additive tablet administered once orally at study dose in a fasted state.
|
Oral tablet
|
|
Experimental: MK-1403 FM2 + additive, Fed
MK-1403 FM2 tablet + additive administered once orally at study dose after a high-fat meal.
|
Oral tablet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants Who Experience an Adverse Event (AE)
Time Frame: Up to approximately 4 weeks
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention.
|
Up to approximately 4 weeks
|
|
Number of Participants Who Discontinue the Study Intervention Due to an AE
Time Frame: Up to approximately 2 weeks
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention.
|
Up to approximately 2 weeks
|
|
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-inf) of MK-1403
Time Frame: Predose and at designated timepoints (up to 72 hours postdose)
|
Blood samples will be collected to determine the AUC0-inf of MK-1403 in plasma.
|
Predose and at designated timepoints (up to 72 hours postdose)
|
|
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-last) of MK-1403
Time Frame: Predose and at designated timepoints (up to 72 hours postdose)
|
Blood samples will be collected to determine the AUC0-last of MK-1403 in plasma.
|
Predose and at designated timepoints (up to 72 hours postdose)
|
|
Maximum Plasma Concentration (Cmax) of MK-1403
Time Frame: Predose and at designated timepoints (up to 72 hours postdose)
|
Blood samples will be collected to determine the Cmax of MK-1403 in plasma.
|
Predose and at designated timepoints (up to 72 hours postdose)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
August 14, 2026
Primary Completion (Estimated)
September 22, 2026
Study Completion (Estimated)
September 22, 2026
Study Registration Dates
First Submitted
June 24, 2026
First Submitted That Met QC Criteria
June 24, 2026
First Posted (Actual)
June 30, 2026
Study Record Updates
Last Update Posted (Actual)
September 16, 2026
Last Update Submitted That Met QC Criteria
September 15, 2026
Last Verified
September 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- 1403-007
- MK-1403-007 (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.