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| ID | Type | Description | Link |
|---|---|---|---|
| MK-0616-033 | Other Identifier | MSD |
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The goal of the study is to learn what happens to enlicitide decanoate in a healthy person's body over time when taken on an empty stomach or with food. Researchers will compare what happens to enlicitide in a healthy person's body over time when enlicitide is taken with or without food. Enlicitide decanoate will be referred to as "enlicitide" throughout.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enlicitide Treatment A | Experimental | Participants receive single oral dose of enlicitide after 8-hour overnight fast. |
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| Enlicitide Treatment B | Experimental | Participants receive single oral dose of enlicitide 4 hours after morning meal. |
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| Enlicitide Treatment C | Experimental | Participants receive single oral dose of enlicitide 3 hours after morning meal. |
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| Enlicitide Treatment D | Experimental | Participants receive single oral dose of enlicitide 2 hours after morning meal. |
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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 versus Time Curve from 0 to Infinity (AUC0-inf) of enlicitide in plasma | AUC0-inf of enlicitide in plasma will be determined. | Pre-dose and at designated time points up to 168 hours post dose |
| Area Under the Concentration versus Time Curve from Time 0 to 24 hours (AUC0-24) of enlicitide in plasma | AUC0-24 of enlicitide in plasma will be determined. | Pre-dose and at designated time points up to 24 hours post dose |
| Area under the concentration versus time curve from time 0 to last quantifiable sample (AUC0-last) of enlicitide in plasma | AUC0-last of enlicitide in plasma will be determined. | Pre-dose and at designated time points up to 168 hours post dose |
| Maximum plasma concentration (Cmax) of enlicitide in plasma | Cmax of enlicitide in plasma will be determined. | Pre-dose and at designated time points up to 168 hours post dose |
| Time to maximum plasma concentration (Tmax) of enlicitide in plasma | Tmax of enlicitide in plasma will be determined. | Pre-dose and at designated time points up to 168 hours post dose |
| Apparent terminal half-life (t1/2) of enlicitide in plasma | t1/2 of enlicitide in plasma will be determined. | Pre-dose and at designated time points up to 168 hours post dose |
| Apparent Clearance (CL/F) of enlicitide in plasma |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who experience one or more adverse events (AEs) | 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. | Up to ~ 14 days |
| Number of participants who discontinue study intervention due to an AE |
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Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
- Has body mass index (BMI) ≥18 kg/m^2 and ≤32 kg/m^2
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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CL/F of enlicitide in plasma will be determined. |
| Pre-dose and at designated time points up to 168 hours post dose |
| Apparent volume of distribution during terminal phase (Vz/F) of enlicitide in plasma | Vz/F of enlicitide in plasma will be determined. | Pre-dose and at designated time points up to 168 hours post dose |
| Lag Time (tlag) of enlicitide in plasma | tlag is the time from dosing to the first appearance in plasma. The tlag of enlicitide in plasma will be determined. | Pre-dose and at designated time points up to 168 hours post dose |
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. |
| Up to ~ 14 days |