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| ID | Type | Description | Link |
|---|---|---|---|
| MK-0616-009 | Other Identifier | MSD |
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The goal of the study is to learn what happens to levels of MK-0616 in the blood when MK-0616 is given in different forms. Researchers believe that there is no effect on a healthy person's body if MK-0616 is given in different forms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1: MK-0616 Reference capsule→MK-0616 Formulation 1 (F1)→MK-0616 Formulation 2 (F2) | Experimental | Period 1: Participants receive MK-0616 reference capsule single dose on Day 1 orally (Period 1 = 15 days). Period 2: Participants receive MK-0616 F1 single dose on Day 1 orally (Period 2 = 15 days). Period 3: Participants receive MK-0616 F2 single dose on Day 1 orally (Period 3 = 15 days). A washout period of 14 days will separate Period 1, Period 2 and Period 3. |
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| Sequence 2: MK-0616 Reference capsule→MK-0616 F2→MK-0616 F1 | Experimental | Period 1: Participants receive MK-0616 reference capsule single dose on Day 1 orally (Period 1 = 15 days). Period 2: Participants receive MK-0616 F2 single dose on Day 1 orally (Period 2 = 15 days). Period 3: Participants receive MK-0616 F1 single dose on Day 1 orally (Period 3 = 15 days). A washout period of 14 days will separate Period 1, Period 2 and Period 3. |
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| Sequence 3: MK-0616 F1→MK-0616 Reference capsule→MK-0616 F2 | Experimental | Period 1: Participants receive MK-0616 F1 single dose on Day 1 orally (Period 1 = 15 days). Period 2: Participants receive MK-0616 reference capsule single dose on Day 1 orally (Period 2 = 15 days). Period 3: Participants receive MK-0616 F2 single dose on Day 1 orally (Period 3 = 15 days). A washout period of 14 days will separate Period 1, Period 2 and Period 3. |
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| Sequence 4: MK-0616 F1→MK-0616 F2→MK-0616 Reference capsule | Experimental | Period 1: Participants receive MK-0616 F1 single dose on Day 1 orally (Period 1 = 15 days). Period 2: Participants receive MK-0616 F2 single dose on Day 1 orally (Period 2 = 15 days). Period 3: Participants receive MK-0616 reference capsule single dose on Day 1 orally (Period 3 = 15 days). A washout period of 14 days will separate Period 1, Period 2 and Period 3. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-0616 | Drug | oral administration |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-0616 | Blood samples will be collected to determine the AUC0-inf of MK-0616. | Predose and at designated timepoints up to 168 hours postdose |
| Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hr) of MK-0616 | Blood samples will be collected to determine the AUC0-24 of MK-0616. | Predose and at designated timepoints up to 24 hours postdose |
| Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of MK-0616 | Blood samples will be collected to determine the AUC0-last of MK-0616. | Predose and at designated timepoints up to 168 hours postdose |
| Maximum Plasma Concentration (Cmax) of MK-0616 | Blood samples will be collected to determine the Cmax of MK-0616. | Predose and at designated timepoints up to 168 hours postdose |
| Maximum Plasma Concentration (C24) of MK-0616 | Blood samples will be collected to determine the C24 of MK-0616. | Predose and at designated timepoints up to 24 hours postdose |
| Apparent Terminal Half-life (t1/2) of MK-0616 | Blood samples will be collected to determine the apparent t1/2 of MK-0616. | Predose and at designated timepoints up to 168 hours postdose |
| Time to Maximum Plasma Concentration (Tmax) of MK-0616 |
| 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 2 months |
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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 |
|---|---|---|---|---|---|---|
| QPS-MRA, LLC-Early Phase | South Miami | Florida | 33143 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| C000728674 | MK-0616 |
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| Sequence 5: MK-0616 F2→MK-0616 Reference capsule →MK-0616 F1 | Experimental | Period 1: Participants receive MK-0616 F2 single dose on Day 1 orally (Period 1 = 15 days). Period 2: Participants receive MK-0616 reference capsule single dose on Day 1 orally (Period 2 = 15 days). Period 3: Participants receive MK-0616 F1 single dose on Day 1 orally (Period 3 = 15 days). A washout period of 14 days will separate Period 1, Period 2 and Period 3. |
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| Sequence 6: MK-0616 F2→MK-0616 F1→MK-0616 Reference capsule | Experimental | Period 1: Participants receive MK-0616 F2 single dose on Day 1 orally (Period 1 = 15 days). Period 2: Participants receive MK-0616 F1 single dose on Day 1 orally (Period 2 = 15 days). Period 3: Participants receive MK-0616 reference capsule single dose on Day 1 orally (Period 3 = 15 days). A washout period of 14 days will separate Period 1, Period 2 and Period 3. |
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Blood samples will be collected at pre-specified timepoints to determine the Tmax of MK-0616.
| Predose and at designated timepoints up to 168 hours postdose |
| Number of Participants Who Discontinue Study 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 discontinue study due to an AE will be reported. |
| Up to approximately 2 months |
| D009750 |
| Nutritional and Metabolic Diseases |