Venous Thrombosis
Conditions
Brief summary
The goal of the study is to learn about the safety of MK-2060 and if people tolerate it when MK-2060 is given in different forms.
Interventions
BIOLOGICALMK-2060
Single doses of MK-2060 will be administered via IV infusion or syringe on Day 1 according to randomization.
BIOLOGICALPlacebo
Single doses of placebo will be administered via IV infusion or syringe on Day 1 according to randomization.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 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) between ≥18 and ≤32 kg/m\^2, inclusive
Exclusion criteria
The key
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With An Adverse Event (AE) | Up to 134 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants that experience an AE will be reported. |
| Number of Participants Discontinuing the Study Due to an AE | Up to 134 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants that discontinue the study due to an AE will be reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Plasma Concentration-Time Curve of MK-2060 From Time 0 to 168 Hours (AUC0-168) | Predose and at designated time points post dose up to 120 days | Plasma samples will be collected at pre-specified time points pre- and post-dose to assess AUC0-168 hours. |
| Plasma Concentration of MK-2060 at 168 Hours (C168) | Predose and at designated time points post dose up to 120 days | Plasma samples will be collected at pre-specified time points pre- and post-dose to assess C168 hours. |
| Time to Maximum Observed Plasma Drug Concentration (Tmax) of MK-2060 | Predose and at designated time points post dose up to 120 days | Plasma samples will be collected at pre-specified time points pre- and post-dose to assess Tmax. |
| Area Under the Plasma Concentration-Time Curve of MK-2060 From Time 0 to Infinity (AUC0-inf) | Predose and at designated time points post dose up to 120 days | Plasma samples will be collected at pre-specified time points pre- and post-dose to assess AUC0-inf. |
| Apparent Oral Clearance (CL/F) of MK-2060 | Predose and at designated time points post dose up to 120 days | Plasma samples will be collected at pre-specified time points pre- and post-dose to assess CL/F. |
| Plasma Apparent Volume of Distribution (Vz/F) of MK-2060 | Predose and at designated time points post dose up to 120 days | Plasma samples will be collected at pre-specified time points pre- and post-dose to assess Vz/F. |
| Fold Change From Baseline in Activated Partial Thromboplastin Time (aPTT) of MK-2060 | Baseline and up to 120 days | Plasma samples will be collected at baseline and pre-specified time points post-dose to assess aPTT values. The fold change from baseline will be reported. |
| Plasma Elimination Terminal Half-life (t ½) of MK-2060 | Predose and at designated time points post dose up to 120 days | Plasma samples will be collected at pre-specified time points pre- and post-dose to assess t½ . |
| Maximum Observed Plasma Concentration (Cmax) of MK-2060 | Predose and at designated time points post dose up to 120 days | Plasma samples will be collected at pre-specified time points pre- and post-dose to assess Cmax. |
Countries
United States
Outcome results
None listed