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| ID | Type | Description | Link |
|---|---|---|---|
| MK-0616-028 | Other Identifier | MSD |
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| Name | Class |
|---|---|
| Celerion | INDUSTRY |
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Levothyroxine (T4) is a man-made thyroid hormone used to treat certain thyroid conditions. After taking levothyroxine, a person's body changes it to triiodothyronine (T3). The amount of levothyroxine in a person's blood must be carefully controlled to maintain proper function. Enlicitide decanoate was designed to lower the amount of cholesterol in a person's blood.
Researchers want to learn about levothyroxine when taken at the same time with enlicitide decanoate. They want to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levothyroxine | Experimental | Participants will receive a single oral dose of levothyroxine. |
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| Levothyroxine Plus Enlicitide Decanoate | Experimental | Participants will receive a single oral dose of levothyroxine and a single oral dose of enlicitide decanoate at the same time. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levothyroxine | Drug | single oral dose |
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| Measure | Description | Time Frame |
|---|---|---|
| Area under the Concentration-Time Curve from Time 0 to 48 hours (AUC0-48hrs) of Levothyroxine (total T4) | Blood samples will be collected to determine the AUC0-48hr of Levothyroxine (T4). | At designated timepoints (up to approximately 48 hours postdose) |
| Maximum Plasma Concentration (Cmax) of Levothyroxine (total T4) | Blood samples will be collected to determine the Cmax of Levothyroxine (T4). | At designated timepoints (up to approximately 48 hours postdose) |
| Time to Maximum Plasma Concentration (Tmax) of Levothyroxine (total T4) | Blood samples will be collected to determine the Tmax of Levothyroxine (T4). | At designated timepoints (up to approximately 48 hours postdose) |
| Area under the Concentration-Time Curve from Time 0 to 48 hours (AUC0-48hrs) of Triiodothyronine (total T3) | Blood samples will be collected to determine the AUC0-48hr of triiodothyronine (T3). | At designated timepoints (up to approximately 48 hours postdose) |
| Maximum Plasma Concentration (Cmax) of Triiodothyronine (total T3) | Blood samples will be collected to determine the Cmax of triiodothyronine (T3). | At designated timepoints (up to approximately 48 hours postdose) |
| Time to Maximum Plasma Concentration (Tmax) of Triiodothyronine (total T3) | Blood samples will be collected to determine the Tmax of triiodothyronine (T3). | At designated timepoints (up to approximately 48 hours postdose) |
| 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 0001) | Lincoln | Nebraska | 68502 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| ID | Term |
|---|---|
| D013974 | Thyroxine |
| C000728674 | MK-0616 |
| ID | Term |
|---|---|
| D013963 | Thyroid Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D024322 | Amino Acids, Aromatic |
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| Enlicitide Decanoate | Drug | single oral dose |
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| Up to approximately 7 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 7 weeks |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |