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| ID | Type | Description | Link |
|---|---|---|---|
| MK-0616-025 | Other Identifier | MSD |
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The purpose of this study is to learn what happens to the amount of enlicitide decanoate in the blood when enlicitide decanoate is given in different formulations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enlicitide Decanoate Treatment A | Experimental | Participants will receive a single dose of enlicitide decanoate formulation 1 on Day 1 on an empty stomach. |
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| Enlicitide Decanoate Treatment B | Experimental | Participants will receive a single dose of enlicitide decanoate formulation 2 on Day 1 on an empty stomach. |
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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 0 to 24 hours (AUC0-24) of enlicitide decanoate | Blood samples will be collected to determine the AUC0-24 of enlicitide decanoate. | Predose and at designated timepoints (up to 24 hours postdose) |
| Area Under the Concentration-Time Curve from 0 to Time of Last Quantifiable Sample (AUC0-last) of enlicitide decanoate | Blood samples will be collected to determine the AUC0-last of enlicitide decanoate. | Predose and at designated timepoints (up to 168 hours postdose) |
| Area Under the Concentration-Time Curve from 0 to Infinity (AUC0-inf) of enlicitide decanoate | Blood samples will be collected to determine the AUC0-inf of enlicitide decanoate. | Predose and at designated timepoints (up to 168 hours postdose) |
| Maximum Plasma Concentration (Cmax) of enlicitide decanoate | Blood samples will be collected to determine the Cmax of enlicitide decanoate. | Predose and at designated timepoints (up to 168 hours postdose) |
| Time to Maximum Plasma Concentration (Tmax) of enlicitide decanoate | Blood samples will be collected to determine the Tmax of enlicitide decanoate. | Predose and at designated timepoints (up to 168 hours postdose) |
| Apparent Terminal Half-Life (t1/2) of enlicitide decanoate | Blood samples will be collected to determine the t1/2 of enlicitide decanoate. | Predose and at designated timepoints (up to 168 hours 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 the study intervention, whether or not considered related to the study intervention. | Up to approximately 44 days |
| Number of Participants Who Discontinue Study Treatment Due to an AE |
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Inclusion Criteria:
Exclusion Criteria:
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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 Clearance (CL/F) of enlicitide decanoate | Blood samples will be collected to determine the CL/F of enlicitide decanoate. | Predose and at designated timepoints (up to 168 hours 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. | Predose and at designated timepoints (up to 168 hours postdose) |
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 44 days |