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| ID | Type | Description | Link |
|---|---|---|---|
| MK-1403-007 | Other Identifier | MSD |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| MK-1403 FM1 + additive, Fasted | Experimental | MK-1403 FM1 + additive tablet administered once orally at study dose in a fasted state. |
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| MK-1403 FM2 + additive, Fed | Experimental | MK-1403 FM2 tablet + additive administered once orally at study dose after a high-fat meal. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-1403 formulation (FM) 1 + additive | Drug | Oral tablet |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharpe & Dohme LLC | Study Director |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| MK-1403 FM2 + additive | Drug | Oral tablet |
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