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| ID | Type | Description | Link |
|---|---|---|---|
| MK-0616-026 | Other Identifier | MSD |
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The main goal of this study is to learn what happens in a person's body over time when they take enlicitide decanoate with warfarin or lisinopril. Researchers want to learn if the amount of warfarin in a person's blood is similar when warfarin is taken alone or with enlicitide decanoate.
Enlicitide decanoate is a new medicine that lowers the amount of cholesterol in a person's blood. Warfarin is a drug that reduces risk of blood clotting, and lisinopril is a drug that lowers blood pressure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Warfarin Plus Enlicitide Decanoate | Experimental | Participants receive oral warfarin and oral enlicitide decanoate. |
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| Lisinopril Plus Enlicitide Decanoate | Experimental | Participants receive oral lisinopril and oral enlicitide decanoate. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Warfarin | Drug | single oral dose |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Warfarin | Blood samples will be collected to determine the AUC0-Inf of warfarin. | At designated timepoints (up to approximately 2 weeks postdose) |
| Area Under the Concentration-Time Curve from Time 0 to Last Measurable Concentration (AUC0-Last) of Warfarin | Blood samples will be collected to determine the AUC0-Last of warfarin. | At designated timepoints (up to approximately 2 weeks postdose) |
| Maximum Plasma Concentration (Cmax) of Warfarin | Blood samples will be collected to determine the Cmax of warfarin. | At designated timepoints (up to approximately 2 weeks postdose) |
| Time to Maximum Plasma Concentration (Tmax) of Warfarin | Blood samples will be collected to determine the Tmax of warfarin. | At designated timepoints (up to approximately 2 weeks postdose) |
| Apparent Terminal Half-life (t½) of Warfarin | Blood samples will be collected to determine the t½ of warfarin. | At designated timepoints (up to approximately 2 weeks postdose) |
| Apparent Clearance (CL/F) of Warfarin | Blood samples will be collected to determine the CL/F of warfarin. | At designated timepoints (up to approximately 2 weeks postdose) |
| Apparent Volume of Distribution During Terminal Phase (Vz/F) of Warfarin |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experience a Treatment-Emergent Adverse Event (TEAE) in Part 1 | An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE will be considered treatment-emergent if the onset date and time is at the time of or after first study drug administration. The number of participants who experience a TEAE in Part 1 will be reported. |
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Inclusion Criteria:
The key inclusion criteria include but are not limited to:
Exclusion Criteria:
The key exclusion criteria include but are not limited to:
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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) | Tempe | Arizona | 85283 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| ID | Term |
|---|---|
| D014859 | Warfarin |
| D025101 | Vitamin B 6 |
| C000728674 | MK-0616 |
| D017706 | Lisinopril |
| ID | Term |
|---|---|
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 |
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| Enlicitide Decanoate | Drug | single oral dose |
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| Lisinopril | Drug | single oral dose |
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Blood samples will be collected to determine the Vz/F of warfarin. |
| At designated timepoints (up to approximately 2 weeks postdose) |
| Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Lisinopril | Blood samples will be collected to determine the AUC0-Inf of lisinopril. | At designated timepoints (up to approximately 3 days postdose) |
| Area Under the Concentration-Time Curve from Time 0 to Last Measurable Concentration (AUC0-Last) of Lisinopril | Blood samples will be collected to determine the AUC0-Last of lisinopril. | At designated timepoints (up to approximately 3 days postdose) |
| Maximum Plasma Concentration (Cmax) of Lisinopril | Blood samples will be collected to determine the Cmax of lisinopril. | At designated timepoints (up to approximately 3 days postdose) |
| Time to Maximum Plasma Concentration (Tmax) of Lisinopril | Blood samples will be collected to determine the Tmax of lisinopril. | At designated timepoints (up to approximately 3 days postdose) |
| Apparent Terminal Half-life (t½) of Lisinopril | Blood samples will be collected to determine the t½ of lisinopril. | At designated timepoints (up to approximately 3 days postdose) |
| Apparent Clearance (CL/F) of Lisinopril | Blood samples will be collected to determine the CL/F of lisinopril. | At designated timepoints (up to approximately 3 days postdose) |
| Apparent Volume of Distribution During Terminal Phase (Vz/F) of Lisinopril | Blood samples will be collected to determine the Vz/F of lisinopril. | At designated timepoints (up to approximately 3 days postdose) |
| Up to approximately 5 weeks |
| Number of Participants Who Discontinue Study due to a TEAE in Part 1 | An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE will be considered treatment-emergent if the onset date and time is at the time of or after first study drug administration. The number of participants who discontinue study due to a TEAE in Part 1 will be reported. | Up to approximately 5 weeks |
| Number of Participants Who Experience a Treatment-Emergent Adverse Event (TEAE) in Part 2 | An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE will be considered treatment-emergent if the onset date and time is at the time of or after first study drug administration. The number of participants who experience a TEAE in Part 2 will be reported. | Up to approximately 28 days |
| Number of Participants Who Discontinue Study due to a TEAE in Part 2 | An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE will be considered treatment-emergent if the onset date and time is at the time of or after first study drug administration. The number of participants who discontinue study due to a TEAE in Part 2 will be reported. | Up to approximately 28 days |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010847 | Picolines |
| D011725 | Pyridines |
| D004151 | Dipeptides |
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |