A Study of MK-2060 in Healthy Participants (MK-2060-016)
NCT Number: NCT06582602
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Venous Thrombosis
Interventions: BIOLOGICAL: MK-2060|BIOLOGICAL: Placebo
Sponsor: Merck Sharp & Dohme LLC
Sex: ALL
Age: ADULT
Enrollment: 64
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-24
Completion Date: 2025-03-19

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.

Primary Outcome Measures: Number of Participants With An Adverse Event (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. 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., Up to 134 days|Number of Participants Discontinuing the 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. 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., Up to 134 days
Secondary Outcome Measures: Area Under the Plasma Concentration-Time Curve of MK-2060 From Time 0 to Infinity (AUC0-inf), Plasma samples will be collected at pre-specified time points pre- and post-dose to assess AUC0-inf., Predose and at designated time points post dose up to 120 days|Maximum Observed Plasma Concentration (Cmax) of MK-2060, Plasma samples will be collected at pre-specified time points pre- and post-dose to assess Cmax., Predose and at designated time points post dose up to 120 days|Area Under the Plasma Concentration-Time Curve of MK-2060 From Time 0 to 168 Hours (AUC0-168), Plasma samples will be collected at pre-specified time points pre- and post-dose to assess AUC0-168 hours., Predose and at designated time points post dose up to 120 days|Plasma Concentration of MK-2060 at 168 Hours (C168), Plasma samples will be collected at pre-specified time points pre- and post-dose to assess C168 hours., Predose and at designated time points post dose up to 120 days|Time to Maximum Observed Plasma Drug Concentration (Tmax) of MK-2060, Plasma samples will be collected at pre-specified time points pre- and post-dose to assess Tmax., Predose and at designated time points post dose up to 120 days|Plasma Elimination Terminal Half-life (t ½) of MK-2060, Plasma samples will be collected at pre-specified time points pre- and post-dose to assess t½ ., Predose and at designated time points post dose up to 120 days|Apparent Oral Clearance (CL/F) of MK-2060, Plasma samples will be collected at pre-specified time points pre- and post-dose to assess CL/F., Predose and at designated time points post dose up to 120 days|Plasma Apparent Volume of Distribution (Vz/F) of MK-2060, Plasma samples will be collected at pre-specified time points pre- and post-dose to assess Vz/F., Predose and at designated time points post dose up to 120 days|Fold Change From Baseline in Activated Partial Thromboplastin Time (aPTT) of MK-2060, 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., Baseline and up to 120 days