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

Phase 1

Recruiting

• Conditions: Healthy
• Interventions: Drug: [14C]MK-8527

• Registration Number: NCT06826989
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-10
• Study First Submitted QC: 2025-02-10
• Study First Posted: 2025-02-14
• Status Verified: 2025-03
• Study Start: 2025-03-19
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-09
• Primary Completion: 2025-05-07
• Study Completion: 2025-05-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Cumulative Percentage of Total Radioactivity Recovered (fe) from Urine and Feces	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.
Fe from Urine	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.
Plasma MK-8527: Area Under the Concentration-Time Curve from Time 0 to 24 Hours Post-dose (AUC0-24)	At designated timepoints (up to 24 hours post-dose)	Plasma samples will be collected to determine the AUC0-24 of MK-8527.
Plasma MK-8527: Maximum Observed Concentration (Cmax)	At designated timepoints (up to approximately 14 days post-dose)	Plasma samples will be collected to determine the Cmax of MK-8527.
Fe from Feces	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.
Plasma MK-8527: Concentration at 24 Hours Post-dose (C24)	At designated timepoints (up to 24 hours post-dose)	Plasma samples will be collected to determine the C24 of MK-8527.
Plasma MK-8527: Time of the Maximum Observed Concentration (Tmax)	At designated timepoints (up to approximately 14 days post-dose)	Plasma samples will be collected to determine the Tmax of MK-8527.
Plasma Total Radioactivity: AUC0-24	At designated timepoints (up to 24 hours post-dose)	Plasma samples will be collected to determine the AUC0-24 of total radioactivity.
Plasma Total Radioactivity: Cmax	At designated timepoints (up to approximately 5 weeks post-dose)	Plasma samples will be collected to determine the Cmax of total radioactivity.
Plasma Total Radioactivity: C24	At designated timepoints (up to 24 hours post-dose)	Plasma samples will be collected to determine the C24 of total radioactivity.
Plasma Total Radioactivity: Tmax	At designated timepoints (up to approximately 5 weeks post-dose)	Plasma samples will be collected to determine the Tmax of total radioactivity.
Whole Blood Total Radioactivity: AUC0-24	At designated timepoints (up to 24 hours post-dose)	Whole blood samples will be collected to determine the AUC0-24 of total radioactivity.
Whole Blood Total Radioactivity: Cmax	At designated timepoints (up to approximately 5 weeks post-dose)	Whole blood samples will be collected to determine the Cmax of total radioactivity.
Whole Blood Total Radioactivity: C24	At designated timepoints (up to 24 hours post-dose)	Whole blood samples will be collected to determine the C24 of total radioactivity.
Whole blood Total Radioactivity: Tmax	At designated timepoints (up to approximately 5 weeks post-dose)	Whole blood samples will be collected to determine the Tmax of total radioactivity.
Cumulative Amount of Radioactivity Recovered from Urine	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.
Percent of Total Radioactive Dose Recovered from Urine	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.
Cumulative Amount of Radioactivity Recovered from Feces	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.
Percent of Total Radioactive Dose Recovered from Feces	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.
Total Number of Metabolites in Plasma that Represent at least 10% of the Dose of Radioactivity	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.
Total Number of Metabolites in Urine that Represent at least 10% of the Dose of Radioactivity	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.
Total Number of Metabolites in Feces that Represent at least 10% of the Dose of Radioactivity	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 Outcome Measures

Name	Time	Method
Number of Participants Who Experience an Adverse Event (AE)	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.
Number of Participants Who Discontinue the Study Due to an AE	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.

Trial Locations

Locations (1)

Fortea CRU Madison ( 0001); 🇺🇸 Madison, Wisconsin, United States