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NCT Number: NCT07677163

A Clinical Trial of MK-1403 in Healthy Participants (MK-1403-007)

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MK-1403 formulation (FM) 1 + additive

Drug

Oral tablet

MK-1403 FM2 + additive

Drug

Oral tablet

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Clinical Study to Evaluate the Relative Bioavailability of MK-1403 Formulations Administered to Healthy Adult Participants

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 30, 2026
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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