A Clinical Study To Understand How Radiolabeled MK-5475 Is Taken Up By The Body, Broken Down And Then Removed From The Body in Healthy Participants (MK-5475-011)

October 27, 2025 updated by: Merck Sharp & Dohme LLC

An Open-label Phase 1 IV Study to Evaluate Metabolism, Excretion, and Mass Balance of [14C]MK-5475 in Healthy Participants

The goal of this study is to understand how radiolabeled MK-5475 administered intravenously (IV) is taken up by the body, broken down and then removed from the body in healthy male participants. The study also aims to understand how much of the compound is broken down and how much leaves the body unchanged.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53704
        • Labcorp Clinical Research Unit Inc. (Site 0001)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Is in good health.
  • Body mass index (BMI) >18 and ≤32 kg/m2, inclusive.

Exclusion Criteria:

  • Has history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases.
  • Has significant multiple and/or severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription drugs or food.
  • Has had a major surgery and/or donated or lost 1 unit of blood (approximately 500 mL) or blood products within 4 weeks prior to the prestudy (screening).
  • Has history of exposure to significant diagnostic or therapeutic radiation or current employment in a job requiring radiation exposure monitoring within 12 months prior to check-in.
  • Has participated in more than 3 radiolabeled drug studies in the last 12 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: [14C] MK-5475
[14C] MK-5475 is administered as single IV bolus dose of 100μg on Day 1.
Drug: [14C] MK-5475
[14C] MK-5475 is administered as a single IV bolus dose in healthy male participants on Day 1.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Amount Excreted in Urine (Aeu)
Time Frame: At designated time points (Up to ~ 23 days)
Amount of [14C]MK-5475 and its metabolites excreted in urine (Aeu) derived from urine collections at each sampling interval.
At designated time points (Up to ~ 23 days)
Cumulative Aeu
Time Frame: At designated time points (Up to ~ 23 days)
Cumulative amount of [14C] MK-5475 and its metabolites excreted in urine derived from urine collections at each sampling interval
At designated time points (Up to ~ 23 days)
Percentage Excreted in Urine (feu)
Time Frame: At designated time points (Up to ~ 23 days)
Percentage of [14C]MK-5475 and its metabolites excreted in urine derived from urine collections at each sampling interval.
At designated time points (Up to ~ 23 days)
Cumulative feu
Time Frame: At designated time points (Up to ~ 23 days)
Cumulative percentage of [14C]MK-5475 and its metabolites excreted in urine derived from urine collections at each sampling interval.
At designated time points (Up to ~ 23 days)
Amount Excreted in Feces (Aef)
Time Frame: At designated time points (Up to ~ 23 days)
Amount of [14C]MK-5475 and its metabolites excreted in feces derived from feces collections at each sampling interval.
At designated time points (Up to ~ 23 days)
Cumulative Aef
Time Frame: At designated time points (Up to ~ 23 days)
Cumulative amount of [14C]MK-5475 and its metabolites excreted in feces derived from feces collections at each sampling interval.
At designated time points (Up to ~ 23 days)
Cumulative Fef
Time Frame: At designated time points (Up to ~ 23 days)
Cumulative percentage of [14C]MK-5475 and its metabolites excreted in feces derived from feces collections at each sampling interval.
At designated time points (Up to ~ 23 days)
AUC0-t
Time Frame: At designated time points (Up to ~ 23 days)
Area under concentration time curve (AUC) from time zero to the last quantifiable concentration derived from the whole blood and plasma concentration-time profiles following IV administration of [14C]MK-5475.
At designated time points (Up to ~ 23 days)
AUC0-infinity
Time Frame: At designated time points (Up to ~ 23 days)
AUC from time zero extrapolated to infinity derived from the whole blood and plasma concentration-time profiles following IV administration of [14C]MK-5475.
At designated time points (Up to ~ 23 days)
Maximum Plasma Concentration (Cmax)
Time Frame: At designated time points (Up to ~ 23 days)
Cmax is the measure of the maximum amount of [14C]MK-5475 in the plasma after the dose is given.
At designated time points (Up to ~ 23 days)
Half-life t1/2
Time Frame: At designated time points (Up to ~ 23 days)
T1/2 is the time required for [14C]MK-5475 concentration in the plasma to decrease by 50%.
At designated time points (Up to ~ 23 days)
Time to Maximum Plasma Concentration (Tmax),
Time Frame: At designated time points (Up to ~ 23 days)
Tmax is a measure of the time to reach the maximum concentration in the plasma after the [14C]MK-5475 dose.
At designated time points (Up to ~ 23 days)
Apparent Total Clearance (CL; MK-5475 only)
Time Frame: At designated time points (Up to ~ 23 days)
CL is defined as apparent total clearance of [14C]MK-5475 from plasma after IV administration
At designated time points (Up to ~ 23 days)
Apparent Volume of Distribution (Vz; MK-5475 only)
Time Frame: At designated time points (Up to ~ 23 days)
Vz is defined as apparent volume of distribution of [14C]MK-5475 during terminal phase after IV administration.
At designated time points (Up to ~ 23 days)
AUC0-infinity Plasma [14C]MK-5475/Total Radioactivity Ratio
Time Frame: At designated time points (Up to ~ 23 days)
AUC time zero to infinity (0-∞) of [14C]MK-5475 in plasma/AUC0-∞ of total radioactivity in plasma.
At designated time points (Up to ~ 23 days)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants Who Experience an Adverse Event (AE)
Time Frame: Up to ~ 30 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. The number of participants who experience an AE will be reported.
Up to ~ 30 days
Number of Participants Who Discontinue Study Due to an AE
Time Frame: Up to ~ 30 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. The number of participants who discontinue study due to an AE will be reported.
Up to ~ 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Merck Sharp & Dohme LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 15, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 25, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 10, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 16, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 5475-011
  • MK-5475-011 (Other Identifier: MSD)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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