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

Purpose

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.

Condition

  • Healthy

Eligibility

Eligible Ages
Between 18 Years and 55 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Basic Science
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Drug: MK-1403 formulation (FM) 1 + additive
    Oral tablet
Experimental
MK-1403 FM1 + additive, Fasted
MK-1403 FM1 + additive tablet administered once orally at study dose in a fasted state.
  • Drug: MK-1403 formulation (FM) 1 + additive
    Oral tablet
Experimental
MK-1403 FM2 + additive, Fed
MK-1403 FM2 tablet + additive administered once orally at study dose after a high-fat meal.
  • Drug: MK-1403 FM2 + additive
    Oral tablet

Recruiting Locations

Qps-Mra, Llc
Miami, Florida 33143
Contact:
Study Coordinator

More Details

Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@msd.com