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| ID | Type | Description | Link |
|---|---|---|---|
| MK-0616-016 | Other Identifier | MSD |
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The purpose of this study is to learn what happens to enlicitide chloride labeled with [¹⁴C] in a person's body over time. A label can be added to a study medicine to trace it in a person's body.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [¹⁴C]Enlicitide chloride | Experimental | Participants will receive a single dose of [¹⁴C]enlicitide chloride on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [¹⁴C]Enlicitide chloride | Drug | IV Injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Amount of Radioactivity Excreted in Urine (Aeu) | Urine samples will be collected to determine the Aeu of [¹⁴C]enlicitide chloride. | At designated timepoints (up to 15 days) |
| Cumulative Amount of Radioactivity Excreted in Feces (Aef) | Fecal samples will be collected to determine the Aef of [¹⁴C]enlicitide chloride. | At designated timepoints (up to 15 days) |
| Cumulative Percentage of Radioactivity Excreted in Urine (feu) | Urine samples will be collected to determine the feu of [¹⁴C]enlicitide chloride. | At designated timepoints (up to 15 days) |
| Cumulative Percentage of Radioactivity Excreted in Feces (fef) | Fecal samples will be collected to determine the fef of [¹⁴C]enlicitide chloride. | At designated timepoints (up to 15 days) |
| Plasma Enlicitide Chloride: Area Under the Concentration-Time Curve from Time 0 to the Last Measurable Concentration (AUC0-t) | Plasma samples will be collected to determine the AUC0-t of enlicitide chloride. | At designated timepoints (up to 15 days) |
| Plasma Enlicitide Chloride: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-inf) | Plasma samples will be collected to determine the AUC0-inf of enlicitide chloride. | At designated timepoints (up to 15 days) |
| Plasma Enlicitide Chloride: Maximum Plasma Concentration (Cmax) |
| 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 29 days |
| Number of Participants Who Discontinue the Study 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 |
|---|---|---|---|---|---|---|
| Labcorp Clinical Research Unit Inc. (Site 0001) | Madison | Wisconsin | 53704 | 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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Plasma samples will be collected to determine the Cmax of enlicitide chloride. |
| At designated timepoints (up to 15 days) |
| Plasma Enlicitide Chloride: Apparent Terminal Half-life (t1/2) | Plasma samples will be collected to determine the t1/2 of enlicitide chloride. | At designated timepoints (up to 15 days) |
| Plasma Enlicitide Chloride: Time to Maximum Plasma Concentration (Tmax) | Plasma samples will be collected to determine the Tmax of enlicitide chloride. | At designated timepoints (up to 15 days) |
| Plasma Total Reactivity: AUC0-t | Plasma samples will be collected to determine the AUC0-t of total reactivity. | At designated timepoints (up to 15 days) |
| Plasma Total Reactivity: AUC0-inf | Plasma samples will be collected to determine the AUC0-inf of total reactivity. | At designated timepoints (up to 15 days) |
| Plasma Total Reactivity: Cmax | Plasma samples will be collected to determine the Cmax of total reactivity. | At designated timepoints (up to 15 days) |
| Plasma Total Reactivity: t1/2 | Plasma samples will be collected to determine the t1/2 of total reactivity. | At designated timepoints (up to 15 days) |
| Plasma Total Reactivity: Tmax | Plasma samples will be collected to determine the Tmax of total reactivity. | At designated timepoints (up to 15 days) |
| Enlicitide Chloride to Total Radioactivity Ratio of Area Under the Concentration-Time Curve from Time 0 to the Last Detectable Sample (enlicitide chloride AUC0-x/total radioactivity AUC0-x) | Plasma samples will be collected to determine the enlicitide chloride AUC0-x/total radioactivity AUC0-x. | At designated timepoints (up to 15 days) |
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 29 days |