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| ID | Type | Description | Link |
|---|---|---|---|
| MK-0616-035 | Other Identifier | MSD |
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The goal of the study is to learn what happens to different forms of enlicitide medications in a healthy person's body over time. Researchers will compare the amount of enlicitide in the healthy person's body over time when enlicitide is given in different formulations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A: enlicitide reference tablet | Experimental | Participants receive a single oral dose of enlicitide reference tablet. |
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| Treatment B: enlicitide test tablet | Experimental | Participants receive a single oral dose of enlicitide test tablet. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enlicitide | Drug | Oral Tablet |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of enlicitide in plasma | Blood samples will be collected to determine the AUC0-24hr of enlicitide. | Pre-dose and at designated time points up to 24 hours post dose |
| Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of enlicitide in plasma | Blood samples will be collected to determine the AUC0-Last of enlicitide. | Pre-dose and at designated time points up to 168 hours post dose |
| Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of enlicitide in plasma | Blood samples will be collected to determine the AUC0-Inf of enlicitide. | Pre-dose and at designated time points up to 168 hours post dose |
| Maximum Plasma Concentration (Cmax) of enlicitide in plasma | Blood samples will be collected to determine the Cmax of enlicitide. | Pre-dose and at designated time points up to 168 hours post dose |
| 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 approximately 14 days |
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Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The main 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) | Tempe | Arizona | 85283 | 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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| Number of Participants Who Discontinue Study Treatment 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 treatment due to an AE will be reported. | Up to approximately 8 days |