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This goal of this trial is to learn about two medicines, enlicitide and rosuvastatin, in healthy people. Researchers will compare the amounts of enlicitide and rosuvastatin in a person's body over time, when they are given as separate medicines and when they are combined into one tablet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enlicitide + Rosuvastatin Part 1 | Experimental | Participants in Part 1 will receive a single dose of enlicitide tablet coadministered with a single dose of rosuvastatin tablet |
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| MK-0616A Part 1 | Experimental | Participants in Part 1 will receive a single dose of MK-0616A |
|
| Enlicitide + Rosuvastatin Part 2 | Experimental | Participants in Part 2 will receive a single dose of enlicitide tablet coadministered with a single dose of rosuvastatin tablet |
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| MK-0616A Part 2 | Experimental | Participants in Part 2 will receive a single dose of MK-0616A formulation B |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-0616A | Drug | Enlicitide/rosuvastatin fixed dose combination (FDC) or enlicitide/rosuvastatin FDC formulation B oral tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 in plasma | Pre dose and at designated time points up to 168 hours post dose |
| AUC0-Inf of Rosuvastatin | Blood samples will be collected to determine the AUC0-inf of rosuvastatin in plasma | Pre dose and at designated time points up to 168 hours post dose |
| Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Enlicitde | Blood samples will be collected to determine the AUC0-last of enlicitide in plasma | Pre dose and at designated time points up to 168 hours post dose |
| AUC0-Last of Rosuvastatin | Blood samples will be collected to determine the AUC0-last of rosuvastatin in plasma | Pre dose and at designated time points up to 168 hours post dose |
| Maximum Plasma Concentration (Cmax) of Enlicitide | Blood samples will be collected to determine the cmax of enlicitide in plasma | Pre dose and at designated time points up to 168 hours post dose |
| Cmax of Rosuvastatin | Blood samples will be collected to determine the cmax of rosuvastatin in plasma | Pre dose and at designated time points up to 168 hours post dose |
| 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. The number of participants who experience an AE will be reported. | Up to approximately 9 weeks |
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The main inclusion criteria include but are not limited to the following:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Toll Free Number | Contact | 1-888-577-8839 | Trialsites@msd.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion ( Site 0001) | Recruiting | Tempe | Arizona | 85283 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| C000728674 | MK-0616 |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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| Enlicitide | Drug | Oral tablet |
|
|
| Rosuvastatin | Drug | Oral tablet |
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| 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 8 days after first dose |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |