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Not yet recruiting NCT07677163

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

Phase I Interventional Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MK-1403 formulation (FM) 1 + additive, MK-1403 FM2 + additive.
Who it may be relevant to
Registry conditions: Healthy. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug MK-1403 formulation (FM) 1 + additive
    Oral tablet
  • Drug MK-1403 FM2 + additive
    Oral tablet

Primary outcome measures

  • 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)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Basic science

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07677163 · 1403-007 · MK-1403-007

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗