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| ID | Type | Description | Link |
|---|---|---|---|
| MK-2060-009 | Other Identifier | MSD |
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The goal of the study is to learn about the safety of MK-2060 and if people tolerate it. Researchers also want to learn what happens to MK-2060 in a person's body over time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Panel A: MK-2060 Dose 1 | Experimental | MK-2060 dose 1 was administered as a single intravenous (IV) infusion dose on Day 1. |
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| Panel B: MK-2060 Dose 2 | Experimental | MK-2060 dose 2 was administered as a single IV infusion dose on Day 1. There was at least a 21-day period between dosing in Panel A and B. |
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| Panel C: MK-2060 Dose 3 | Experimental | MK-2060 dose 3 was administered as a single IV infusion dose on Day 1. There was at least a 21-day period between dosing in Panel B and C. |
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| Placebo | Placebo Comparator | Placebo was administered as a single IV infusion over MK-2060-matched time period on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-2060 | Biological | Single doses of MK-2060 administered via IV infusion on Day 1 according to randomization. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who experience one or more adverse events (AEs) | 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. | Up to 164 days |
| 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 study intervention, whether or not considered related to the study intervention. | Up to 164 days |
| Number of participants who experience one or more AEs related to bleeding | A bleeding related AE includes any sign or symptom of bleeding even if not requiring intervention by a medical/ healthcare professional, to clinically-relevant non major bleeding or major bleeding. | Up to 164 days |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration at end of infusion (Ceoi) of MK-2060 | Ceoi is defined as the amount of MK-2060 in plasma following IV infusion administration of MK-2060. Blood samples were collected at pre-specified time points to assess Ceoi. | Predose Day 1 and end of infusion |
| Plasma concentration at 168 hours (C168hr) of MK-2060 |
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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 |
|---|---|---|---|---|---|---|
| Zhongshan Hospital,Fudan University-Dep. of Clinical Pharmacology (Site 001) | Shanghai | Shanghai Municipality | 200032 | China |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| Placebo | Biological | Single doses of placebo administered via IV infusion on Day 1 according to randomization. |
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C168 is defined as the maximum concentration of MK-2060 reached at 168 hours postdose. Blood samples were collected at pre-specified time points to assess C168hr. |
| At designated timepoints (up to 168 hours) |
| Area under the concentration versus time curve from 0 to infinity (AUC0-inf) of MK-2060 | AUC0-inf is defined as the area under the concentration-time curve of MK-2060 from time zero to infinity. Blood samples were collected at pre-specified time points to assess AUC0-inf. | At designated timepoints (up to 150 days) |
| AUC from 0 to 168 hours (AUC0-168) of MK-2060 | AUC0-168 is defined as the area under the concentration-time curve of MK-2060 from time zero to 168 hours. Blood samples were collected at pre-specified time points to assess AUC0-168. | At designated timepoints (up to 168 hours) |
| Time to maximum observed plasma drug concentration (Tmax) of MK-2060 | Tmax is defined as time to the maximum concentration of MK-2060 reached. Blood samples were collected at pre-specified time points to assess Tmax. | At designated timepoints (up to 150 days) |
| Terminal half-life of MK-2060 | t½ is defined as the time required to divide the MK-2060 plasma concentration by two after reaching pseudo-equilibrium, following a single dose of MK-2060. Blood samples were collected at pre-specified time points to assess terminal half-life. | At designated timepoints (up to 150 days) |
| Clearance (CL) of MK-2060 | CL is the volume of plasma from which MK-2060 is completely removed per unit time. Blood samples were collected at pre-specified time points to assess CL. | At designated timepoints (up to 150 days) |
| Volume of distribution (Vz) of MK-2060 | Vz is defined as the distributed volume of MK-2060 in plasma. Blood samples were collected at pre-specified time points to assess Vz. | At designated timepoints (up to 150 days) |
| Change from baseline in activated partial thromboplastin time (aPTT) | Blood samples were collected at pre-specified time points to assess change from baseline in aPTT. | Baseline (pre-dose) Day 1 and at designated timepoints (up to 150 days) |
| Anti-drug antibodies (ADA) positive incidence | Blood samples were collected at pre-specified time points to assess the incidence of anti-MK-2060 antibodies. | At designated timepoints (up to 150 days) |
| Factor XI (FXI) activity level | Blood samples were collected at pre-specified time points to assess FXI activity level. | At designated timepoints (up to 150 days) |
| Prothrombin time (PT) | Blood samples were collected at pre-specified time points to assess PT. | At designated timepoints (up to 150 days) |