Recruiting
Phase 1

MK-1403

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT07677163

Conditions

Healthy

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

MK-1403 formulation (FM) 1 + additive

MK-1403 FM2 + additive

Study Details

Brief 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).

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

Study ID

NCT07677163

Start date

Aug 14, 2026

Status verified date

Aug, 2026

Completion date

Sep 22, 2026

Anticipated

Primary completion date

Sep 22, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

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 Design

Enrollment

15 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

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.

experimental: MK-1403 FM1 + additive, Fasted

MK-1403 FM1 + additive tablet administered once orally at study dose in a fasted state.

experimental: MK-1403 FM2 + additive, Fed

MK-1403 FM2 tablet + additive administered once orally at study dose after a high-fat meal.

Interventions

MK-1403 formulation (FM) 1 + additive

Oral tablet

MK-1403 FM2 + additive

Oral tablet

Primary outcome measure

  • Number of Participants Who Experience an Adverse Event (AE) [ Time Frame: Up to approximately 4 weeks ]
  • Number of Participants Who Discontinue the Study Intervention Due to an AE [ Time Frame: 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) ]
  • 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) ]
  • Maximum Plasma Concentration (Cmax) of MK-1403 [ Time Frame: Predose and at designated timepoints (up to 72 hours postdose) ]

Central Contacts and Locations

Central contacts

Toll Free Number

1-888-577-8839Trialsites@msd.com

Locations

Qps-Mra, Llc

Recruiting

Miami, Florida, United States, 33143

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-08-19.