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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
8
Oral Dose
Fortea CRU Madison ( 0001)
Madison, Wisconsin, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At designated timepoints (up to approximately 14 days post-dose)
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Plasma Total Radioactivity: AUC0-24
Plasma samples will be collected to determine the AUC0-24 of total radioactivity.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At designated timepoints (up to approximately 5 weeks post-dose)
Number of Participants Who Experience an Adverse Event (AE)
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.
Time frame: Up to approximately 7 weeks
Number of Participants Who Discontinue the Study Due to an AE
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.
Time frame: Up to approximately 7 weeks