Clinical trial NCT06826989: A Study of MK-8527 in Healthy Adult Participants (MK-8527-013)
Official title: A Phase 1 Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]MK-8527 in Healthy Adult Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2025-02-14
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Cumulative Percentage of Total Radioactivity Recovered (fe) from Urine and Feces
timeFrame: At designated timepoints (up to approximately 5 weeks post-dose)
measure: Fe from Urine
timeFrame: At designated timepoints (up to approximately 5 weeks post-dose)
measure: Fe from Feces
timeFrame: At designated timepoints (up to approximately 5 weeks post-dose)
measure: Plasma MK-8527: Area Under the Concentration-Time Curve from Time 0 to 24 Hours Post-dose (AUC0-24)
timeFrame: At designated timepoints (up to 24 hours post-dose)
measure: Plasma MK-8527: Maximum Observed Concentration (Cmax)
timeFrame: At designated timepoints (up to approximately 14 days post-dose)
measure: Plasma MK-8527: Concentration at 24 Hours Post-dose (C24)
timeFrame: At designated timepoints (up to 24 hours post-dose)
measure: Plasma MK-8527: Time of the Maximum Observed Concentration (Tmax)
timeFrame: At designated timepoints (up to approximately 14 days post-dose)
measure: Plasma Total Radioactivity: AUC0-24
timeFrame: At designated timepoints (up to 24 hours post-dose)
measure: Plasma Total Radioactivity: Cmax
timeFrame: At designated timepoints (up to approximately 5 weeks post-dose)
measure: Plasma Total Radioactivity: C24
timeFrame: At designated timepoints (up to 24 hours post-dose)
measure: Plasma Total Radioactivity: Tmax
timeFrame: At designated timepoints (up to approximately 5 weeks post-dose)
measure: Whole Blood Total Radioactivity: AUC0-24
timeFrame: At designated timepoints (up to 24 hours post-dose)
measure: Whole Blood Total Radioactivity: Cmax
timeFrame: At designated timepoints (up to approximately 5 weeks post-dose)
measure: Whole Blood Total Radioactivity: C24
timeFrame: At designated timepoints (up to 24 hours post-dose)
measure: Whole blood Total Radioactivity: Tmax
timeFrame: At designated timepoints (up to approximately 5 weeks post-dose)
measure: Cumulative Amount of Radioactivity Recovered from Urine
timeFrame: At designated timepoints (up to approximately 5 weeks post-dose)
measure: Percent of Total Radioactive Dose Recovered from Urine
timeFrame: At designated timepoints (up to approximately 5 weeks post-dose)
measure: Cumulative Amount of Radioactivity Recovered from Feces
timeFrame: At designated timepoints (up to approximately 5 weeks post-dose)
measure: Percent of Total Radioactive Dose Recovered from Feces
timeFrame: At designated timepoints (up to approximately 5 weeks post-dose)
measure: Total Number of Metabolites in Plasma that Represent at least 10% of the Dose of Radioactivity
timeFrame: At designated timepoints (up to approximately 5 weeks post-dose)
measure: Total Number of Metabolites in Urine that Represent at least 10% of the Dose of Radioactivity
timeFrame: At designated timepoints (up to approximately 5 weeks post-dose)
measure: Total Number of Metabolites in Feces that Represent at least 10% of the Dose of Radioactivity
timeFrame: At designated timepoints (up to approximately 5 weeks post-dose)
Secondary outcomes:
measure: Number of Participants Who Experience an Adverse Event (AE)
timeFrame: Up to approximately 7 weeks
measure: Number of Participants Who Discontinue the Study Due to an AE
timeFrame: Up to approximately 7 weeks
Other outcomes:
Locations:
city: Madison
country: United States
facility: Fortea CRU Madison ( 0001)
state: Wisconsin
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: