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| ID | Type | Description | Link |
|---|---|---|---|
| MK-0616 | Other Identifier | MSD |
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Enlicitide decanoate (MK-0616, the study medicine) is in a class of medicines that have been shown to reduce LDL-C. Enlicitide decanoate is different from the other medicines in this class because it is taken as a tablet and not an injection.
The goal of this study is to see what happens to doses of enlicitide decanoate in a person's body over time. During the study, researchers will measure people's blood samples for the amount of enlicitide decanoate when taken with food or on an empty stomach, or when taken with high, medium, and low volumes of water. Researchers also want to learn about the safety of enlicitide decanoate, including how well people tolerate (manage) it.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enlicitide Decanoate Food Effect | Experimental | Participants will be administered enlicitide decanoate on Day 1 with or without food. |
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| Enlicitide Decanoate Water Effect | Experimental | Participants will be administered enlicitide decanoate on Day 1 with high, medium, and low volumes of water. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enlicitide decanoate | Drug | Oral tablet |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Enlicitide Decanoate | Blood samples will be collected to determine the AUC0-Inf of enlicitide decanoate. | Pre-dose and at designated time points up to 1 week postdose |
| Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of Enlicitide Decanoate | Blood samples will be collected to determine the AUC0-24 of enlicitide decanoate. | Pre-dose and at designated time points up to 24 hours postdose |
| Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Enlicitide Decanoate | Blood samples will be collected to determine the AUC0-last of enlicitide decanoate. | Pre-dose and at designated time points up to 1 week postdose |
| Maximum Plasma Concentration (Cmax) of Enlicitide Decanoate | Blood samples will be collected to determine the Cmax of enlicitide decanoate. | Pre-dose and at designated time points up to 1 week postdose |
| Time to Maximum Plasma Concentration (Tmax) of Enlicitide Decanoate | Blood samples will be collected to determine the Tmax of enlicitide decanoate. | Pre-dose and at designated time points up to 1 week postdose |
| Lag Time (tlag) of Enlicitide Decanoate in Plasma | Tlag is the time from dosing to the first appearance in plasma. Blood samples will be collected to determine the tlag of enlicitide decanoate. | Pre-dose and at designated time points up to 1 week postdose |
| 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 study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported. | Up to 14 days postdose |
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Inclusion Criteria:
The key inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The key exclusion criteria include but are not limited to the following:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion (Site 0001) | Lincoln | Nebraska | 68502 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| ID | Term |
|---|---|
| C000728674 | MK-0616 |
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| Apparent Terminal Half-life (t1/2) of Enlicitide Decanoate | Blood samples will be collected to determine the t1/2 of enlicitide decanoate. | Pre-dose and at designated time points up to 1 week postdose |
| Apparent Clearance (CL/F) of Enlicitide Decanoate | Blood samples will be collected to determine the CL/F of enlicitide decanoate. | Pre-dose and at designated time points up to 1 week postdose |
| Apparent Volume of Distribution During Terminal Phase (Vz/F) of Enlicitide Decanoate | Blood samples will be collected to determine the Vz/F of enlicitide decanoate. | Pre-dose and at designated time points up to 1 week postdose |
| Number of Participants Who Discontinue Study Due to an AE | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study due to an AE will be reported. | Up to 14 days postdose |