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| ID | Type | Description | Link |
|---|---|---|---|
| MK-0616-010 | Other Identifier | MSD |
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The purpose of this study is to learn about the safety of enlicitide chloride and how well people tolerate it. Researchers also want to learn what happens to different amounts of enlicitide chloride in a healthy person's body over time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enlicitide Chloride Panel A | Experimental | Period 1: Participants will receive a single dose of enlicitide chloride dose 1 or a single dose of placebo on Day 1 on an empty stomach (after a ≥8-hour overnight fast). Period 2: Participants will receive a single dose of enlicitide chloride dose 1 or a single dose of placebo on Day 1 on an empty stomach (after a ≥8-hour overnight fast) followed by a standard breakfast. |
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| Enlicitide Chloride Panel B | Experimental | Period 1: Participants will receive a single dose of enlicitide chloride dose 2 or a single dose of placebo on Day 1 on an empty stomach (after a ≥8-hour overnight fast). Period 2: Participants will receive a single dose of enlicitide chloride dose 3 or a single dose of placebo on Day 1 on an empty stomach (after a ≥8-hour overnight fast). |
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| Enlicitide Chloride Panel C | Experimental | Participants will receive enlicitide chloride dose 2 or placebo once daily for 14 days on an empty stomach (after a ≥8-hour overnight fast). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enlicitide Chloride | Drug | Oral Capsule |
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| 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 study intervention, whether or not considered related to the study intervention | Up to approximately 2 months |
| Number of Participants Who Discontinue the 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 | Up to approximately 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Panels A and B: Area Under the Concentration-Time Curve from 0 to Infinity (AUC0-inf) of Enlicitide Chloride | Blood samples will be collected to determine the AUC0-inf of enlicitide chloride | Predose and at designated timepoints (up to 8 days postdose) |
| Panels A and B: Area Under the Concentration-Time Curve from 0 to 24 Hours (AUC0-24) of Enlicitide Chloride |
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Inclusion Criteria:
Inclusion criteria include, but are not limited to:
Exclusion Criteria:
Exclusion criteria include, but are not limited to:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharpe & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital,Fudan University-Dep. of Clinical Pharmacology (Site 0001) | Shanghai | Shanghai Municipality | 200032 | China |
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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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Additional Roles Masked: Sponsor
| Placebo | Drug | Placebo oral capsule matching enlicitide chloride |
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Blood samples will be collected to determine the AUC0-24 of enlicitide chloride |
| Predose and at designated timepoints (up to 24 hours postdose) |
| Panels A and B: Area Under the Concentration-Time Curve from 0 to Last Measurable Concentration (AUC0-last) of Enlicitide Chloride | Blood samples will be collected to determine the AUC0-last of enlicitide chloride | Predose and at designated timepoints (up to 8 days postdose) |
| Panels A and B: Maximum Plasma Concentration (Cmax) of Enlicitide Chloride | Blood samples will be collected to determine the Cmax of enlicitide chloride | Predose and at designated timepoints (up to 8 days postdose) |
| Panels A and B: Time to Maximum Plasma Concentration (Tmax) of Enlicitide Chloride | Blood samples will be collected to determine the Tmax of enlicitide chloride | Predose and at designated timepoints (up to 8 days postdose) |
| Panels A and B: Concentration at 24 Hours Postdose (C24) of Enlicitide Chloride | Blood samples will be collected to determine the C24 of enlicitide chloride | 24 hours postdose |
| Panels A and B: Apparent Terminal Half-Life (t1/2) of Enlicitide Chloride | Blood samples will be collected to determine the apparent terminal t1/2 of enlicitide chloride | Predose and at designated timepoints (up to 8 days postdose) |
| Panels A and B: Apparent Clearance (CL/F) of Enlicitide Chloride | Blood samples will be collected to determine the CL/F of enlicitide chloride | Predose and at designated timepoints (up to 8 days postdose) |
| Panels A and B: Apparent Volume of Distribution During Terminal Phase (Vz/F) of Enlicitide Chloride | Blood samples will be collected to determine the Vz/F of enlicitide chloride | Predose and at designated timepoints (up to 8 days postdose) |
| Panels A and B: Percent of Reduction of Serum Low Density Lipoprotein Cholesterol (LDL-C) | Blood samples will be collected to determine the percent of reduction of serum LDL-C | Predose and at designated timepoints (up to 8 days postdose) |
| Panel C: AUC0-24 of Enlicitide Chloride | Blood samples will be collected to determine the AUC0-24 of enlicitide chloride | Predose and at designated timepoints (up to 24 hours postdose) |
| Panel C: Cmax of Enlicitide Chloride | Blood samples will be collected to determine the Cmax of enlicitide chloride | Predose and at designated timepoints (up to 14 days postdose) |
| Panel C: Tmax of Enlicitide Chloride | Blood samples will be collected to determine the Tmax of enlicitide chloride | Predose and at designated timepoints (up to 14 days postdose) |
| Panel C: C24 of Enlicitide Chloride | Blood samples will be collected to determine the C24 of enlicitide chloride | 24 hours postdose |
| Panel C: Apparent Terminal t1/2 of Enlicitide Chloride | Blood samples will be collected to determine the apparent terminal t/2 of enlicitide chloride | Predose and at designated timepoints (up to 14 days postdose) |
| Panel C: CL/F of Enlicitide Chloride | Blood samples will be collected to determine the CL/F of enlicitide chloride | Predose and at designated timepoints (up to 14 days postdose) |
| Panel C: Vz/F of Enlicitide Chloride | Blood samples will be collected to determine the Vz/F of enlicitide chloride | Predose and at designated timepoints (up to 14 days postdose) |
| Panel C: Accumulation Ratio of Enlicitide Chloride | Blood samples will be collected to determine the accumulation ratio of enlicitide chloride | Predose and at designated timepoints (up to 14 days postdose) |
| Panel C: Percent of Reduction of Serum LDL-C | Blood samples will be collected to determine the percent of reduction of serum LDL-C | Predose and at designated timepoints (up to 14 days postdose) |