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| ID | Type | Description | Link |
|---|---|---|---|
| MK-6194-013 | Other Identifier | MSD |
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The goal of this study is to learn what happens to MK-6194 in a healthy person's body when different injection sites are used. Researchers will compare what happens to MK-6194 in a healthy person's body when it is injected into the abdomen and when it is injected into the thigh. Researchers think that the average amount of MK-6194 in a person's body over time will be similar when injected into the thigh or abdomen. They also want to learn if it is safe to inject MK-6194 into the abdomen and thigh, and if people tolerate it.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abdomen Injection | Experimental | Participants will receive a single dose of MK-6194 injected into the abdomen. |
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| Thigh Injection | Experimental | Participants will receive a single dose of MK-6194 injected into the thigh. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-6194 | Biological | single injected dose |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of MK-6194 | Blood samples will be collected to determine the AUC0-Last of MK-6194. | At designated timepoints (up to approximately 4 weeks postdose) |
| Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-6194 | Blood samples will be collected to determine the AUC0-Inf of MK-6194. | At designated timepoints (up to approximately 4 weeks postdose) |
| Maximum Plasma Concentration (Cmax) of MK-6194 | Blood samples will be collected to determine the Cmax of MK-6194. | At designated timepoints (up to approximately 4 weeks postdose) |
| Time to Maximum Plasma Concentration (Tmax) of MK-6194 | Blood samples will be collected to determine the Tmax of MK-6194. | At designated timepoints (up to approximately 4 weeks postdose) |
| Apparent Clearance (CL/F) of MK-6194 | Blood samples will be collected to determine the CL/F of MK-6194. | At designated timepoints (up to approximately 4 weeks postdose) |
| Apparent Terminal Half-life (t1/2) of MK-6194 | Blood samples will be collected to determine the t1/2 of MK-6194. | At designated timepoints (up to approximately 4 weeks postdose) |
| Apparent Volume of Distribution (Vz/F) of MK-6194 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experience an Adverse Event | An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the 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 12 weeks |
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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 (Site 0001) | South Miami | Florida | 33143 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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Blood samples will be collected to determine the Vz/F of MK-6194.
| At designated timepoints (up to approximately 4 weeks postdose) |
| Number of Participants Who Discontinue Study Due to an AE | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study due to an AE will be reported. | Up to approximately 12 weeks |