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

NCT06826989 | Completed Phase 1 FDA Drug

• 2 other identifiers: 8527-013MK-8527-013
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (22)

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

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

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

• Fe from Urine

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

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

• Fe from Feces

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

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

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

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

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

• Plasma MK-8527: Maximum Observed Concentration (Cmax)

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

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

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

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

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

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

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

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

• Plasma Total Radioactivity: AUC0-24

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

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

• Plasma Total Radioactivity: Cmax

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

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

• Plasma Total Radioactivity: C24

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

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

• Plasma Total Radioactivity: Tmax

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

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

• Whole Blood Total Radioactivity: AUC0-24

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

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

• Whole Blood Total Radioactivity: Cmax

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

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

• Whole Blood Total Radioactivity: C24

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

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

• Whole blood Total Radioactivity: Tmax

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

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

• Cumulative Amount of Radioactivity Recovered from Urine

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

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

• Percent of Total Radioactive Dose Recovered from Urine

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

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

• Cumulative Amount of Radioactivity Recovered from Feces

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

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

• Percent of Total Radioactive Dose Recovered from Feces

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

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

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

  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.

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

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

  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.

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

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

  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.

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

Secondary Outcomes (2)

• Number of Participants Who Experience an Adverse Event (AE)

  Up to approximately 7 weeks

• Number of Participants Who Discontinue the Study Due to an AE

  Up to approximately 7 weeks

Study Arms (1)

[14C]MK-8527

EXPERIMENTAL

Participants will receive a single oral dose of \[14C\]MK-8527 on Day 1

Drug: [14C]MK-8527

Interventions

[14C]MK-8527 DRUG

Oral Dose

[14C]MK-8527

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Is in good health
• Has a body mass index (BMI) of 18 to 32 kg/m\^2

You may not qualify if:

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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

Fortea CRU Madison ( 0001)

Madison, Wisconsin, 53704, United States

Location

Related Links

• Merck Clinical Trials Information

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 14, 2025
• Study Start: March 19, 2025
• Primary Completion: June 4, 2025
• Study Completion: June 4, 2025
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)