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| ID | Type | Description | Link |
|---|---|---|---|
| MK-0616-034 | Other Identifier | MSD |
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Researchers have designed a new study medicine called enlicitide decanoate (MK-0616) as a new way to lower the amount of low-density lipoprotein cholesterol (LDL-C) in a person's blood. Enlicitide decanoate will be called "enlicitide" from this point forward. Lithium (also called lithium carbonate) is a medicine used in bipolar disorder.
Researchers want to learn about lithium when taken at the same time with enlicitide.
They want to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lithium Carbonate | Experimental | On Day 1 of Period 1, a single oral dose of lithium carbonate will be administered. |
|
| Enlicitide with Lithium Carbonate | Experimental | On Day 1 of Period 2, a single oral dose of lithium carbonate will be coadministered with a single oral dose of enlicitide. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lithium carbonate | Drug | Oral capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) for Lithium in Plasma | Blood samples will be collected to determine the AUC0-inf of lithium in plasma. | At designated timepoints (up to approximately 5 days post dose) |
| Area Under the Concentration versus Time Curve From Time Zero to Last Quantifiable Sample (AUC0-last) for Lithium in Plasma | Blood samples will be collected to determine the AUC0-last of lithium in plasma. | At designated timepoints (up to approximately 5 days post dose) |
| Cmax (Maximum Concentration) for Lithium in Plasma | Blood samples will be collected determine the Cmax of lithium in plasma. | At designated timepoints (up to approximately 5 days post dose) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants who experience a Treatment Emergent Adverse Event (TEAE) | An adverse event (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. An AE will be considered treatment-emergent if the onset date and time is at the time of or after the first study drug administration. The number of participants who experience a TEAE will be reported. |
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Inclusion Criteria:
The key inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The key exclusion criteria include but are not limited to the following:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion ( Site 0002) | Tempe | Arizona | 85283 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| ID | Term |
|---|---|
| D016651 | Lithium Carbonate |
| D008094 | Lithium |
| ID | Term |
|---|---|
| D002254 | Carbonates |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D002255 | Carbonic Acid |
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| enlicitide | Drug | Oral tablet |
|
|
| Up to approximately 3 weeks |
| Number of Participants Who Discontinue Study Due to a TEAE | 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. An AE will be considered treatment-emergent if the onset date and time is at the time of or after the first study drug administration. The number of participants who discontinue study due to a TEAE will be reported. | Up to approximately 3 weeks |
| D017554 |
| Carbon Compounds, Inorganic |
| D018020 | Lithium Compounds |
| D008672 | Metals, Alkali |
| D004602 | Elements |
| D019565 | Metals, Light |
| D008670 | Metals |