Clinical trial NCT06582602: A Study of MK-2060 in Healthy Participants (MK-2060-016)
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Venous Thrombosis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2024-09-03
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With An Adverse Event (AE)
timeFrame: Up to 134 days
measure: Number of Participants Discontinuing the Study Due to an AE
timeFrame: Up to 134 days
Secondary outcomes:
measure: Area Under the Plasma Concentration-Time Curve of MK-2060 From Time 0 to Infinity (AUC0-inf)
timeFrame: Predose and at designated time points post dose up to 120 days
measure: Maximum Observed Plasma Concentration (Cmax) of MK-2060
timeFrame: Predose and at designated time points post dose up to 120 days
measure: Area Under the Plasma Concentration-Time Curve of MK-2060 From Time 0 to 168 Hours (AUC0-168)
timeFrame: Predose and at designated time points post dose up to 120 days
measure: Plasma Concentration of MK-2060 at 168 Hours (C168)
timeFrame: Predose and at designated time points post dose up to 120 days
measure: Time to Maximum Observed Plasma Drug Concentration (Tmax) of MK-2060
timeFrame: Predose and at designated time points post dose up to 120 days
measure: Plasma Elimination Terminal Half-life (t ½) of MK-2060
timeFrame: Predose and at designated time points post dose up to 120 days
measure: Apparent Oral Clearance (CL/F) of MK-2060
timeFrame: Predose and at designated time points post dose up to 120 days
measure: Plasma Apparent Volume of Distribution (Vz/F) of MK-2060
timeFrame: Predose and at designated time points post dose up to 120 days
measure: Fold Change From Baseline in Activated Partial Thromboplastin Time (aPTT) of MK-2060
timeFrame: Baseline and up to 120 days
Other outcomes:
Locations:
city: Miami
country: United States
facility: Advanced Pharma CR, LLC ( Site 0002)
state: Florida
city: Knoxville
country: United States
facility: Alliance for Multispecialty Research, LLC ( Site 0001)
state: Tennessee
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: