Healthy
Conditions
Brief summary
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.
Interventions
BIOLOGICALMK-2060
Single doses of MK-2060 administered via IV infusion on Day 1 according to randomization.
BIOLOGICALPlacebo
Single doses of placebo administered via IV infusion on Day 1 according to randomization.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
20 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
The key inclusion criteria include but are not limited to the following: * Is in good health before randomization * Has a body mass index (BMI) ≥18 and ≤28 kg/m\^2.
Exclusion criteria
The key
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who experience one or more adverse events (AEs) | Up to 164 days | 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. |
| Number of participants who discontinue study due to an AE | Up to 164 days | 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. |
| Number of participants who experience one or more AEs related to bleeding | Up to 164 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC from 0 to 168 hours (AUC0-168) of MK-2060 | At designated timepoints (up to 168 hours) | 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. |
| Time to maximum observed plasma drug concentration (Tmax) of MK-2060 | At designated timepoints (up to 150 days) | 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. |
| Terminal half-life of MK-2060 | At designated timepoints (up to 150 days) | 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. |
| Clearance (CL) of MK-2060 | At designated timepoints (up to 150 days) | 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. |
| Plasma concentration at end of infusion (Ceoi) of MK-2060 | Predose Day 1 and end of infusion | 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. |
| Change from baseline in activated partial thromboplastin time (aPTT) | Baseline (pre-dose) Day 1 and at designated timepoints (up to 150 days) | Blood samples were collected at pre-specified time points to assess change from baseline in aPTT. |
| Anti-drug antibodies (ADA) positive incidence | At designated timepoints (up to 150 days) | Blood samples were collected at pre-specified time points to assess the incidence of anti-MK-2060 antibodies. |
| Factor XI (FXI) activity level | At designated timepoints (up to 150 days) | Blood samples were collected at pre-specified time points to assess FXI activity level. |
| Prothrombin time (PT) | At designated timepoints (up to 150 days) | Blood samples were collected at pre-specified time points to assess PT. |
| Volume of distribution (Vz) of MK-2060 | At designated timepoints (up to 150 days) | Vz is defined as the distributed volume of MK-2060 in plasma. Blood samples were collected at pre-specified time points to assess Vz. |
| Plasma concentration at 168 hours (C168hr) of MK-2060 | At designated timepoints (up to 168 hours) | 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. |
| Area under the concentration versus time curve from 0 to infinity (AUC0-inf) of MK-2060 | At designated timepoints (up to 150 days) | 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. |
Countries
China
Outcome results
None listed