HealthyPhase 1NCT07677163
A Clinical Trial of MK-1403 in Healthy Participants (MK-1403-007)
A Phase 1 study testing MK-1403 formulation (FM) 1 + additive and MK-1403 FM2 + additive in people with Healthy, run by Merck Sharp & Dohme LLC at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- MK-1403 formulation (FM) 1 + additive and MK-1403 FM2 + additive
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2026to 5 Oct 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Is in good health
- Has a body mass index (BMI) ≥ 18 and ≤ 32 kg/m^2
Who cannot join
- Has history of cancer (malignancy)
- Has a history of significant multiple and/or severe allergies
Trial locations and contacts
1 site in 1 country.
United States1 site
QPS-MRA, LLC ( Site 0001)
South Miami, Florida, 33143
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- MK-1403 formulation (FM) 1 + additive, MK-1403 FM2 + additive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-1403 formulation (FM) 1 + additiveDrug
Oral tablet
MK-1403 FM2 + additiveDrug
Oral tablet
| Study group | Role | What they receive |
|---|---|---|
| MK-1403 formulation (FM) 1 + additive, Fed | Experimental | MK-1403 FM 1 + additive tablet administered once orally at study dose after a high-fat meal. Receives: Drug: MK-1403 formulation (FM) 1 + additive |
| MK-1403 FM1 + additive, Fasted | Experimental | MK-1403 FM1 + additive tablet administered once orally at study dose in a fasted state. Receives: Drug: MK-1403 formulation (FM) 1 + additive |
| MK-1403 FM2 + additive, Fed | Experimental | MK-1403 FM2 tablet + additive administered once orally at study dose after a high-fat meal. Receives: Drug: MK-1403 FM2 + additive |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 the study intervention, whether or not considered related to the study intervention.
Measured: Up to approximately 4 weeks
Number of Participants Who Discontinue the Study Intervention Due to an AE
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.
Measured: Up to approximately 2 weeks
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-inf) of MK-1403
Blood samples will be collected to determine the AUC0-inf of MK-1403 in plasma.
Measured: 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
Blood samples will be collected to determine the AUC0-last of MK-1403 in plasma.
Measured: Predose and at designated timepoints (up to 72 hours postdose)
Maximum Plasma Concentration (Cmax) of MK-1403
Blood samples will be collected to determine the Cmax of MK-1403 in plasma.
Measured: Predose and at designated timepoints (up to 72 hours postdose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start14 Aug 2026
- Primary completion5 Oct 2026
- Study completion5 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07677163
- Sponsor's protocol ID
- 1403-007
- Other IDs
- MK-1403-007
- Status last verified
- Oct 2026
- First submitted
- 24 Jun 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Relative Bioavailability of MK-1403 Formulations Administered to Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT07677163
- Acronym / sponsor ID
- 1403-007
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 14 Aug 2026 (actual)
- Primary completion
- 5 Oct 2026 (actual)
- Study completion
- 5 Oct 2026 (actual)
- First posted
- 30 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MK-1403 formulation (FM) 1 + additive, Fed | Experimental | Drug: MK-1403 formulation (FM) 1 + additiveMK-1403 FM 1 + additive tablet administered once orally at study dose after a high-fat meal. |
| MK-1403 FM1 + additive, Fasted | Experimental | Drug: MK-1403 formulation (FM) 1 + additiveMK-1403 FM1 + additive tablet administered once orally at study dose in a fasted state. |
| MK-1403 FM2 + additive, Fed | Experimental | Drug: MK-1403 FM2 + additiveMK-1403 FM2 tablet + additive administered once orally at study dose after a high-fat meal. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Is in good health
- Has a body mass index (BMI) ≥ 18 and ≤ 32 kg/m^2
Key exclusion criteria (2 listed)
- Has history of cancer (malignancy)
- Has a history of significant multiple and/or severe allergies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MK-1403 formulation (FM) 1 + additiveOral tablet | Drug | MK-1403 FM1 + additive, Fasted, MK-1403 formulation (FM) 1 + additive, Fed |
| MK-1403 FM2 + additiveOral tablet | Drug | MK-1403 FM2 + additive, Fed |
Primary outcome
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MK-1403 formulation (FM) 1 + additive and MK-1403 FM2 + additive in people with Healthy, run by Merck Sharp & Dohme LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Experience an Adverse Event (AE) (time frame: Up to approximately 4 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.