Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| MK-8527-013 | Other Identifier | MSD |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]MK-8527 | Experimental | Participants will receive a single oral dose of [14C]MK-8527 on Day 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]MK-8527 | Drug | Oral Dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to approximately 7 weeks |
| Number of Participants Who Discontinue the Study Due to an AE |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fortea CRU Madison ( 0001) | Madison | Wisconsin | 53704 | United States |
Not provided
| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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) |
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. |
| Up to approximately 7 weeks |