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| ID | Type | Description | Link |
|---|---|---|---|
| MK-0616-040 | Other Identifier | Merck |
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The goal of this study is to learn what happens to enlicitide in a person's body over time when enlicitide is taken at the same time as coffee or tea. Researchers will measure the amount of enlicitide in the blood when taken with coffee or tea compared with enlicitide taken with water.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enlicitide Coffee Sequence 1 | Experimental | Participants will be randomized to receive enlicitide administered with water in period 1 and enlicitide with coffee in period 2. |
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| Enlicitide Coffee Sequence 2 | Experimental | Participants will be randomized to receive enlicitide administered with coffee in period 1 and enlicitide with water in period 2. |
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| Enlicitide Tea Sequence 1 | Experimental | Participants will be randomized to receive enlicitide administered with water in period 1 and enlicitide with tea in period 2. |
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| Enlicitide Tea Sequence 2 | Experimental | Participants will be randomized to receive enlicitide administered with tea in period 1 and enlicitide with water in period 2. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enlicitide | Drug | Single dose of enlicitide is administered orally on day 1 of each testing period |
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| Measure | Description | Time Frame |
|---|---|---|
| Part 1-Coffee: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Enlicitide | Blood samples will be collected to determine the AUC0-inf of enlicitide when administered with coffee | Predose and at designated time points up to 168 hours |
| Part 1-Coffee: Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-last) of Enlicitide | Blood samples will be collected to determine the AUC from time 0 to the time of last quantifiable sample of enlicitide when administered with coffee | Predose and at designated time points up to 168 hours |
| Part 1 -Coffee : Maximum Plasma Concentration (Cmax) of Enlicitide | Blood samples will be collected to determine the maximum observed drug concentration of enlicitide when administered with coffee | Predose and at designated time points up to 168 hours |
| Part 2 -Tea: AUC0-last of Enlicitide | Blood samples will be collected to determine the AUC from time 0 to the time of last quantifiable sample of enlicitide when administered with tea | Predose and at designated time points up to 168 hours |
| Part 2 - Tea: AUC0-Inf of Enlicitide | Blood samples will be collected to determine the AUC0-inf of enlicitide when administered with tea. | Predose and at designated time points up to 168 hours |
| Part 2 -Tea: Cmax of Enlicitide | Blood samples will be collected to determine the maximum observed drug concentration of enlicitide when administered with tea |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1 - Coffee: Number of Participants Who Experience an Adverse Event (AE) | An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported. | Up to approximately 7 weeks |
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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, Inc. ( 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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| Predose and at designated time points up to 168 hours |
| Part 2 - Tea: Number of Participants Who Experience an Adverse Event (AE) | An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported. | Up to approximately 7 weeks |
| Part 1 - Coffee: 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 7 weeks |
| Part 2 - Tea: 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 7 weeks |