A Study of MK-2060 in Healthy Participants (MK-2060-016)

Phase 1

Completed

• Conditions: Venous Thrombosis
• Interventions: Biological: MK-2060; Biological: Placebo

• Registration Number: NCT06582602
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-30
• Study First Submitted QC: 2024-08-30
• Study First Posted: 2024-09-03
• Study Start: 2024-10-15
• Primary Completion: 2025-04-18
• Study Completion: 2025-04-18
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-16
• Last Update Posted: 2025-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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 exclusion criteria include but are not limited to the following:

• Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
• Has a history of cancer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Panel D: MK-2060 IV (2.5 minutes)	MK-2060	Participants will receive a single dose of MK-2060 via syringe over 2.5 minutes on Day 1.
Panel A: MK-2060 IV (20 minutes)	MK-2060	Participants will receive a single dose of MK-2060 via intravenous (IV) infusion over 20 minutes on Day 1.
Panel B: MK-2060 IV (10 minutes)	MK-2060	Participants will receive a single dose of MK-2060 via IV infusion over 10 minutes on Day 1.
Panel E: MK-2060 IV (1 minute)	MK-2060	Participants will receive a single dose of MK-2060 via syringe over 1 minute on Day 1.
Panel C: MK-2060 IV (5 minutes)	MK-2060	Participants will receive a single dose of MK-2060 via syringe over 5 minutes on Day 1.
Placebo	Placebo	Participants will receive a single dose of saline via IV infusion or syringe over MK-2060-matched time period on Day 1.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.
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 .
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.

Trial Locations

Locations (2)

Advanced Pharma CR, LLC ( Site 0002); 🇺🇸 Miami, Florida, United States

Alliance for Multispecialty Research, LLC ( Site 0001); 🇺🇸 Knoxville, Tennessee, United States