Venous ThrombosisPhase 1NCT06582602
A Study of MK-2060 in Healthy Participants (MK-2060-016)
A Phase 1 study testing MK-2060 in people with Venous Thrombosis, run by Merck Sharp & Dohme LLC at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Venous Thrombosis
- What is being tested?
- MK-2060
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Oct 2024to 18 Apr 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Alliance for Multispecialty Research, LLC ( Site 0001)
Knoxville, Tennessee, 37920
Advanced Pharma CR, LLC ( Site 0002)
Miami, Florida, 33147
About this study
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
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.
- Conditions
- Venous Thrombosis
- Being tested
- MK-2060, Placebo
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-2060Biological
Single doses of MK-2060 will be administered via IV infusion or syringe on Day 1 according to randomization.
PlaceboBiological
Single doses of placebo will be administered via IV infusion or syringe on Day 1 according to randomization.
| Study group | Role | What they receive |
|---|---|---|
| Panel A: MK-2060 IV (20 minutes) | Experimental | Participants will receive a single dose of MK-2060 via intravenous (IV) infusion over 20 minutes on Day 1. Receives: Biological: MK-2060 |
| Panel B: MK-2060 IV (10 minutes) | Experimental | Participants will receive a single dose of MK-2060 via IV infusion over 10 minutes on Day 1. Receives: Biological: MK-2060 |
| Panel C: MK-2060 IV (5 minutes) | Experimental | Participants will receive a single dose of MK-2060 via syringe over 5 minutes on Day 1. Receives: Biological: MK-2060 |
| Panel D: MK-2060 IV (2.5 minutes) | Experimental | Participants will receive a single dose of MK-2060 via syringe over 2.5 minutes on Day 1. Receives: Biological: MK-2060 |
| Panel E: MK-2060 IV (1 minute) | Experimental | Participants will receive a single dose of MK-2060 via syringe over 1 minute on Day 1. Receives: Biological: MK-2060 |
| Placebo | Placebo comparator | Participants will receive a single dose of saline via IV infusion or syringe over MK-2060-matched time period on Day 1. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 134 days
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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 .
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and up to 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start15 Oct 2024
- Primary completion18 Apr 2025
- Study completion18 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThrombosisStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06582602
- Sponsor's protocol ID
- 2060-016
- Other IDs
- MK-2060-016
- Status last verified
- May 2025
- First submitted
- 30 Aug 2024
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06582602
- Acronym / sponsor ID
- 2060-016
- Conditions
- Venous Thrombosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 18 Apr 2025 (actual)
- Study completion
- 18 Apr 2025 (actual)
- First posted
- 3 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Panel A: MK-2060 IV (20 minutes) | Experimental | Biological: MK-2060Participants 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) | Experimental | Biological: MK-2060Participants will receive a single dose of MK-2060 via IV infusion over 10 minutes on Day 1. |
| Panel C: MK-2060 IV (5 minutes) | Experimental | Biological: MK-2060Participants will receive a single dose of MK-2060 via syringe over 5 minutes on Day 1. |
| Panel D: MK-2060 IV (2.5 minutes) | Experimental | Biological: MK-2060Participants will receive a single dose of MK-2060 via syringe over 2.5 minutes on Day 1. |
| Panel E: MK-2060 IV (1 minute) | Experimental | Biological: MK-2060Participants will receive a single dose of MK-2060 via syringe over 1 minute on Day 1. |
| Placebo | Placebo comparator | Biological: PlaceboParticipants will receive a single dose of saline via IV infusion or syringe over MK-2060-matched time period on Day 1. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Is in good health before randomization
- Has a body mass index (BMI) between ≥18 and ≤32 kg/m^2, inclusive
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MK-2060Single doses of MK-2060 will be administered via IV infusion or syringe on Day 1 according to randomization. | Biological | Panel A: MK-2060 IV (20 minutes), Panel B: MK-2060 IV (10 minutes), Panel C: MK-2060 IV (5 minutes), Panel D: MK-2060 IV (2.5 minutes), Panel E: MK-2060 IV (1 minute) |
| PlaceboSingle doses of placebo will be administered via IV infusion or syringe on Day 1 according to randomization. | Biological | Placebo |
Primary outcome
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.
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.
9 secondary outcomes
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
Maximum Observed Plasma Concentration (Cmax) of MK-2060
Time frame: 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)
Time frame: Predose and at designated time points post dose up to 120 days
Plasma Concentration of MK-2060 at 168 Hours (C168)
Time frame: Predose and at designated time points post dose up to 120 days
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 Elimination Terminal Half-life (t ½) of MK-2060
Time frame: Predose and at designated time points post dose up to 120 days
Apparent Oral Clearance (CL/F) of MK-2060
Time frame: Predose and at designated time points post dose up to 120 days
Plasma Apparent Volume of Distribution (Vz/F) of MK-2060
Time frame: 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
Time frame: Baseline and up to 120 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MK-2060 in people with Venous Thrombosis, run by Merck Sharp & Dohme LLC at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With An Adverse Event (AE) (time frame: Up to 134 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.