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| ID | Type | Description | Link |
|---|---|---|---|
| MK-7262-003 | Other Identifier | MSD |
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The goal of this study is to learn what happens to a single dose of enlicitide over time in a healthy participant's body when the participant is given a single dose of MK-7262 and what happens to a single dose of MK-7262 over time in a healthy participant's body when the participant is given a single dose of enlicitide.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MK-7262 | Experimental | Participants will receive MK-7262 orally. |
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| Enlicitide | Experimental | Participants will receive enlicitide orally. |
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| MK-7262 plus Enlicitide | Experimental | Participants will receive MK-7262 and enlicitide orally. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-7262 | Drug | Oral administration |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of MK-7262 | Blood samples will be collected at multiple time points to estimate the AUC0-inf of MK-7262. | Predose and at designated time points post-dose (up to 8 days) |
| AUC0-inf of Enlicitide | Blood samples will be collected at multiple time points to estimate the AUC0-inf of enlicitide. | Predose and at designated time points post-dose (up to 8 days post-dose) |
| Maximum Plasma Concentration (Cmax) of MK-7262 | Blood samples will be collected at multiple time points to estimate the steady-state Cmax of MK-7262. | Predose and at designated time points post-dose (up to 8 days post-dose) |
| Cmax of Enlicitide | Blood samples will be collected at multiple time points to estimate the steady-state Cmax of enlicitide. | Predose and at designated time points post-dose (up to 8 days post-dose) |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time Curve From Time 0 to 24 hours (AUC0-24) of MK-7262 | Blood samples will be collected at multiple time points to estimate the AUC0-24 of MK-7262. | Predose and at designated time points post-dose (up to 24 hours post-dose) |
| Area Under the Concentration-Time Curve From Time 0 to Last Quantifiable Sample (AUC0-last) of MK-7262 |
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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 | Role | Phone | Extension | |
|---|---|---|---|---|
| Toll Free Number | Contact | 1-888-577-8839 | Trialsites@msd.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion ( Site 0001) | Recruiting | 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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| Enlicitide |
| Drug |
Oral administration |
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Blood samples will be collected at multiple time points to estimate the AUC0-last of MK-7262. |
| Predose and at designated time points post-dose (up to 8 days post-dose) |
| Time to Maximum Plasma Concentration (Tmax) of MK-7262 | Blood samples will be collected at multiple time points to estimate the Tmax of MK-7262. | Predose and at designated time points post-dose (up to 8 days post-dose) |
| Apparent Terminal Half-life (t1/2) of MK-7262 | Blood samples will be collected at multiple time points to estimate the t1/2 of MK-7262. | Predose and at designated time points post-dose (up to 8 days post-dose) |
| Apparent Clearance (CL/F) of MK-7262 | Blood samples will be collected at multiple time points to estimate the CL/F of MK-7262. | Predose and at designated time points post-dose (up to 8 days post-dose) |
| Apparent Volume of Distribution During Terminal Phase (Vz/F)of MK-7262 | Blood samples will be collected at multiple time points to estimate the Vz/F of MK-7262. | Predose and at designated time points post-dose (up to 8 days post-dose) |
| AUC0-24 of Enlicitide | Blood samples will be collected at multiple time points to estimate the AUC0-24 of enlicitide. | Predose and at designated time points post-dose (up to 24 hours post-dose) |
| AUC0-last of Enlicitide | Blood samples will be collected at multiple time points to estimate the AUC0-last of enlicitide. | Predose and at designated time points post-dose (up to 8 days post-dose) |
| Tmax of Enlicitide | Blood samples will be collected at multiple time points to estimate the Tmax of enlicitide. | Predose and at designated time points post-dose (up to 8 days post-dose) |
| t1/2 of Enlicitide | Blood samples will be collected at multiple time points to estimate the t1/2 of enlicitide. | Predose and at designated time points post-dose (up to 8 days post-dose) |
| CL/F of Enlicitide | Blood samples will be collected at multiple time points to estimate the CL/F of enlicitide. | Predose and at designated time points post-dose (up to 8 days post-dose) |
| Vz/F of Enlicitide | Blood samples will be collected at multiple time points to estimate the Vz/F of enlicitide. | Predose and at designated time points post-dose (up to 8 days post-dose) |
| 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. The number of participants that experience AEs will be reported. | Up to approximately 8 weeks |
| 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 that discontinue study intervention due to an AE will be reported. | Up to approximately 6 weeks |