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Completed

NCT Number: NCT06582602

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

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.

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Key information

Conditions

Venous Thrombosis Cardiovascular Diseases Embolism and Thrombosis Thrombosis Vascular Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MK-2060

Biological

Single doses of MK-2060 will be administered via IV infusion or syringe on Day 1 according to randomization.

Placebo

Biological

Single doses of placebo will be administered via IV infusion or syringe on Day 1 according to randomization.

Primary outcomes

  1. Number of Participants With An Adverse Event (AE)

    Time frame: 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.

  2. Number of Participants Discontinuing the Study Due to an AE

    Time frame: 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 outcomes

  1. Area Under the Plasma Concentration-Time Curve of MK-2060 From Time 0 to Infinity (AUC0-inf)

    Time frame: 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.

  2. Maximum Observed Plasma Concentration (Cmax) of MK-2060

    Time frame: 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.

  3. Area Under the Plasma Concentration-Time Curve of MK-2060 From Time 0 to 168 Hours (AUC0-168)

    Time frame: 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.

  4. Plasma Concentration of MK-2060 at 168 Hours (C168)

    Time frame: 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.

  5. Time to Maximum Observed Plasma Drug Concentration (Tmax) of MK-2060

    Time frame: 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.

  6. Plasma Elimination Terminal Half-life (t ½) of MK-2060

    Time frame: 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 .

  7. Apparent Oral Clearance (CL/F) of MK-2060

    Time frame: 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.

  8. Plasma Apparent Volume of Distribution (Vz/F) of MK-2060

    Time frame: 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.

  9. Fold Change From Baseline in Activated Partial Thromboplastin Time (aPTT) of MK-2060

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Single Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Intravenous Infusion and Intravenous Bolus Administration of MK-2060 in Healthy Participants

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 3, 2024
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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