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Completed

NCT Number: NCT06777602

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)

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.

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Labcorp Clinical Research Unit Inc. (Site 0001)

Madison, Wisconsin, 53704, United States

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

[14C] MK-5475

Drug

[14C] MK-5475 is administered as a single IV bolus dose in healthy male participants on Day 1.

Primary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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%.

  12. 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.

  13. 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

  14. 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.

  15. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 16, 2025
Registry last updated
Oct 29, 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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