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

NCT07677163 | Not Yet Recruiting Phase 1 FDA Drug

• 2 other identifiers: 1403-007MK-1403-007
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  Predose and at designated timepoints (up to 72 hours postdose)

Study Arms (3)

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.

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.

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.

Drug: MK-1403 FM2 + additive

Interventions

MK-1403 FM2 + additive DRUG

Oral tablet

MK-1403 FM2 + additive, Fed

MK-1403 formulation (FM) 1 + additive DRUG

Oral tablet

MK-1403 FM1 + additive, Fasted; MK-1403 formulation (FM) 1 + additive, Fed

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Has history of cancer (malignancy)
• Has a history of significant multiple and/or severe allergies

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Links

• Merck Clinical Trials Information

Study Officials

• Medical Director

  Merck Sharpe & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: June 30, 2026
• Study Start: July 29, 2026
• Primary Completion (Estimated): September 22, 2026
• Study Completion (Estimated): September 22, 2026
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share