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| ID | Type | Description | Link |
|---|---|---|---|
| MK-0616-024 | Other Identifier | MSD |
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The goal of this study is to learn what happens to enlicitide decanoate and atorvastatin in a healthy person's body over time. Researchers want to learn what happens to enlicitide decanoate in the body when it is given with and without another medicine called atorvastatin and what happens to atorvastatin in the body when it is given with or without enlicitide decanoate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atorvastatin | Experimental | Participants receive a single oral dose of atorvastatin (Treatment A) on Day 1. |
|
| Enlicitide Decanoate + Atorvastatin | Experimental | Participants receive a single oral dose of enlicitide decanoate plus a single oral dose of atorvastatin (Treatment B) on Day 1. |
|
| Enlicitide Decanoate | Experimental | Participants receive a single oral dose of enlicitide decanoate (Treatment C) on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enlicitide Decanoate | Drug | Oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Atorvastatin and its Metabolites | Blood samples will be collected to determine the AUC0-Inf of atorvastatin and its metabolites. | At designated timepoints (up to approximately 8 days) |
| Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Atorvastatin and its Metabolites | Blood samples will be collected to determine the AUC0-Last of atorvastatin and its metabolites. | At designated timepoints (up to approximately 8 days) |
| Maximum Plasma Concentration (Cmax) of Atorvastatin and its Metabolites | Blood samples will be collected to determine the Cmax of atorvastatin and its metabolites. | At designated timepoints (up to approximately 8 days) |
| Time to Maximum Plasma Concentration (Tmax) of Atorvastatin and its Metabolites | Blood samples will be collected to determine the Tmax of atorvastatin and its metabolites. | At designated timepoints (up to approximately 8 days) |
| Apparent Terminal Half-Life (t1/2) of Atorvastatin and its Metabolites | Blood samples will be collected to determine the t1/2 of atorvastatin and its metabolites. | At designated timepoints (up to approximately 8 days) |
| Apparent Clearance (CL/F) of Atorvastatin | Blood samples will be collected to determine the CL/F of atorvastatin. | At designated timepoints (up to approximately 8 days) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 10 weeks |
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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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| Atorvastatin | Drug | Oral administration |
|
|
| Apparent Volume of Distribution (Vz/F) of Atorvastatin | Blood samples will be collected to determine the Vz/F of atorvastatin. | At designated timepoints (up to approximately 8 days) |
| Area Under the Concentration-Time Curve from Time 0 to 24 Hours (AUC0-24hrs) of Enlicitide Decanoate | Blood samples will be collected to determine the AUC0-24hrs of enlicitide decanoate. | At designated timepoints (up to approximately 24 hours) |
| Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Enlicitide Decanoate | Blood samples will be collected to determine the AUC0-Inf of enlicitide decanoate. | At designated timepoints (up to approximately 8 days) |
| Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Enlicitide Decanoate | Blood samples will be collected to determine the AUC0-Last of enlicitide decanoate. | At designated timepoints (up to approximately 8 days) |
| Maximum Plasma Concentration (Cmax) of Enlicitide Decanoate | Blood samples will be collected to determine the Cmax of enlicitide decanoate. | At designated timepoints (up to approximately 8 days) |
| Time to Maximum Plasma Concentration (Tmax) of Enlicitide Decanoate | Blood samples will be collected to determine the Tmax of enlicitide decanoate. | At designated timepoints (up to approximately 8 days) |
| Apparent Terminal Half-Life (t1/2) of Enlicitide Decanoate | Blood samples will be collected to determine the t1/2 of enlicitide decanoate. | At designated timepoints (up to approximately 8 days) |
| Apparent Clearance (CL/F) of Enlicitide Decanoate | Blood samples will be collected to determine the CL/F of enlicitide decanoate. | At designated timepoints (up to approximately 8 days) |
| Apparent Volume of Distribution (Vz/F) of Enlicitide Decanoate | Blood samples will be collected to determine the Vz/F of enlicitide decanoate. | At designated timepoints (up to approximately 8 days) |
| Number of Participants Who Discontinue Study Treatment Due to an 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 6 weeks |
| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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