Healthy
Conditions
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.
Interventions
DRUGMK-1403 formulation (FM) 1 + additive
Oral tablet
DRUGMK-1403 FM2 + additive
Oral tablet
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experience an Adverse Event (AE) | 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. |
| Number of Participants Who Discontinue the Study Intervention Due to an AE | 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. |
| Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-inf) of MK-1403 | 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. |
| Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-last) of MK-1403 | 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. |
| Maximum Plasma Concentration (Cmax) of MK-1403 | Predose and at designated timepoints (up to 72 hours postdose) | Blood samples will be collected to determine the Cmax of MK-1403 in plasma. |
Countries
United States
Contacts
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Outcome results
None listed