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Completed

NCT Number: NCT06826989

A Study of MK-8527 in Healthy Adult Participants (MK-8527-013)

The goal of this study is to learn how [14C]MK-8527 moves through a healthy person's body over time. Researchers will study how [14C]MK-8527 is absorbed by the body, broken down by the body, and how it leaves the body.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Fortea CRU Madison ( 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
  • Has a body mass index (BMI) of 18 to 32 kg/m^2

Exclusion criteria

  • Has a history of cancer
  • Has positive tests for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus

Treatment and study plan

[14C]MK-8527

Drug

Oral Dose

Primary outcomes

  1. Cumulative Percentage of Total Radioactivity Recovered (fe) from Urine and Feces

    Time frame: At designated timepoints (up to approximately 5 weeks post-dose)

    Urine and fecal samples will be collected to determine the cumulative percentage of radioactivity recovered from both urine and feces.

  2. Fe from Urine

    Time frame: At designated timepoints (up to approximately 5 weeks post-dose)

    Urine samples will be collected to determine the percent of total radioactivity recovered from urine.

  3. Fe from Feces

    Time frame: At designated timepoints (up to approximately 5 weeks post-dose)

    Fecal samples will be collected to determine the percent of total radioactivity recovered from feces.

  4. Plasma MK-8527: Area Under the Concentration-Time Curve from Time 0 to 24 Hours Post-dose (AUC0-24)

    Time frame: At designated timepoints (up to 24 hours post-dose)

    Plasma samples will be collected to determine the AUC0-24 of MK-8527.

  5. Plasma MK-8527: Maximum Observed Concentration (Cmax)

    Time frame: At designated timepoints (up to approximately 14 days post-dose)

    Plasma samples will be collected to determine the Cmax of MK-8527.

  6. Plasma MK-8527: Concentration at 24 Hours Post-dose (C24)

    Time frame: At designated timepoints (up to 24 hours post-dose)

    Plasma samples will be collected to determine the C24 of MK-8527.

  7. Plasma MK-8527: Time of the Maximum Observed Concentration (Tmax)

    Time frame: At designated timepoints (up to approximately 14 days post-dose)

    Plasma samples will be collected to determine the Tmax of MK-8527.

  8. Plasma Total Radioactivity: AUC0-24

    Time frame: At designated timepoints (up to 24 hours post-dose)

    Plasma samples will be collected to determine the AUC0-24 of total radioactivity.

  9. Plasma Total Radioactivity: Cmax

    Time frame: At designated timepoints (up to approximately 5 weeks post-dose)

    Plasma samples will be collected to determine the Cmax of total radioactivity.

  10. Plasma Total Radioactivity: C24

    Time frame: At designated timepoints (up to 24 hours post-dose)

    Plasma samples will be collected to determine the C24 of total radioactivity.

  11. Plasma Total Radioactivity: Tmax

    Time frame: At designated timepoints (up to approximately 5 weeks post-dose)

    Plasma samples will be collected to determine the Tmax of total radioactivity.

  12. Whole Blood Total Radioactivity: AUC0-24

    Time frame: At designated timepoints (up to 24 hours post-dose)

    Whole blood samples will be collected to determine the AUC0-24 of total radioactivity.

  13. Whole Blood Total Radioactivity: Cmax

    Time frame: At designated timepoints (up to approximately 5 weeks post-dose)

    Whole blood samples will be collected to determine the Cmax of total radioactivity.

  14. Whole Blood Total Radioactivity: C24

    Time frame: At designated timepoints (up to 24 hours post-dose)

    Whole blood samples will be collected to determine the C24 of total radioactivity.

  15. Whole blood Total Radioactivity: Tmax

    Time frame: At designated timepoints (up to approximately 5 weeks post-dose)

    Whole blood samples will be collected to determine the Tmax of total radioactivity.

  16. Cumulative Amount of Radioactivity Recovered from Urine

    Time frame: At designated timepoints (up to approximately 5 weeks post-dose)

    Urine samples will be collected to determine the cumulative amount of radioactivity recovered from urine.

  17. Percent of Total Radioactive Dose Recovered from Urine

    Time frame: At designated timepoints (up to approximately 5 weeks post-dose)

    Urine samples will be collected to determine the percent of the total radioactive dose recovered from urine.

  18. Cumulative Amount of Radioactivity Recovered from Feces

    Time frame: At designated timepoints (up to approximately 5 weeks post-dose)

    Fecal samples will be collected to determine the cumulative amount of radioactivity recovered from feces.

  19. Percent of Total Radioactive Dose Recovered from Feces

    Time frame: At designated timepoints (up to approximately 5 weeks post-dose)

    Fecal samples will be collected to determine the percent of the total radioactive dose recovered from feces.

  20. Total Number of Metabolites in Plasma that Represent at least 10% of the Dose of Radioactivity

    Time frame: At designated timepoints (up to approximately 5 weeks post-dose)

    Plasma samples will be collected at pre-specified timepoints and used to determine the total number of metabolites that represent at least 10% of the dose of radioactivity. Metabolites will be determined using liquid scintillation and high-resolution mass spectrometry.

  21. Total Number of Metabolites in Urine that Represent at least 10% of the Dose of Radioactivity

    Time frame: At designated timepoints (up to approximately 5 weeks post-dose)

    Urine samples will be collected at pre-specified timepoints and used to determine the total number of metabolites that represent at least 10% of the dose of radioactivity. Metabolites will be determined using liquid scintillation and high-resolution mass spectrometry.

  22. Total Number of Metabolites in Feces that Represent at least 10% of the Dose of Radioactivity

    Time frame: At designated timepoints (up to approximately 5 weeks post-dose)

    Fecal samples will be collected at pre-specified timepoints and used to determine the total number of metabolites that represent at least 10% of the dose of radioactivity. Metabolites will be determined using liquid scintillation and high-resolution mass spectrometry.

Secondary outcomes

  1. Number of Participants Who Experience an Adverse Event (AE)

    Time frame: Up to approximately 7 weeks

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention.

  2. Number of Participants Who Discontinue the Study Due to an AE

    Time frame: Up to approximately 7 weeks

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Phase 1 Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]MK-8527 in Healthy Adult Participants

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 14, 2025
Registry last updated
Jun 11, 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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