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| ID | Type | Description | Link |
|---|---|---|---|
| MK-5475-011 | Other Identifier | MSD |
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The goal of this study is to understand how radiolabeled MK-5475 administered intravenously (IV) is taken up by the body, broken down and then removed from the body in healthy male participants. The study also aims to understand how much of the compound is broken down and how much leaves the body unchanged.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C] MK-5475 | Experimental | [14C] MK-5475 is administered as single IV bolus dose of 100μg on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C] MK-5475 | Drug | [14C] MK-5475 is administered as a single IV bolus dose in healthy male participants on Day 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Amount Excreted in Urine (Aeu) | Amount of [14C]MK-5475 and its metabolites excreted in urine (Aeu) derived from urine collections at each sampling interval. | At designated time points (Up to ~ 23 days) |
| Cumulative Aeu | Cumulative amount of [14C] MK-5475 and its metabolites excreted in urine derived from urine collections at each sampling interval | At designated time points (Up to ~ 23 days) |
| Percentage Excreted in Urine (feu) | Percentage of [14C]MK-5475 and its metabolites excreted in urine derived from urine collections at each sampling interval. | At designated time points (Up to ~ 23 days) |
| Cumulative feu | Cumulative percentage of [14C]MK-5475 and its metabolites excreted in urine derived from urine collections at each sampling interval. | At designated time points (Up to ~ 23 days) |
| Amount Excreted in Feces (Aef) | Amount of [14C]MK-5475 and its metabolites excreted in feces derived from feces collections at each sampling interval. | At designated time points (Up to ~ 23 days) |
| Cumulative Aef | Cumulative amount of [14C]MK-5475 and its metabolites excreted in feces derived from feces collections at each sampling interval. | At designated time points (Up to ~ 23 days) |
| Cumulative Fef |
| 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 study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported. | Up to ~ 30 days |
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Inclusion Criteria:
Exclusion Criteria:
Healthy adult male participants
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Labcorp Clinical Research Unit Inc. (Site 0001) | Madison | Wisconsin | 53704 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40534306 | Result | Menzel K, Liang Y, Chen B, Li D, Cislak D, Bajwa EK. An Intravenous Study with the Radiolabeled sGC Stimulator Frespaciguat to Assess PK, Metabolism, and Mass Balance. J Clin Pharmacol. 2025 Nov;65(11):1561-1567. doi: 10.1002/jcph.70066. Epub 2025 Jun 19. |
| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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Cumulative percentage of [14C]MK-5475 and its metabolites excreted in feces derived from feces collections at each sampling interval.
| At designated time points (Up to ~ 23 days) |
| AUC0-t | Area under concentration time curve (AUC) from time zero to the last quantifiable concentration derived from the whole blood and plasma concentration-time profiles following IV administration of [14C]MK-5475. | At designated time points (Up to ~ 23 days) |
| AUC0-infinity | AUC from time zero extrapolated to infinity derived from the whole blood and plasma concentration-time profiles following IV administration of [14C]MK-5475. | At designated time points (Up to ~ 23 days) |
| Maximum Plasma Concentration (Cmax) | Cmax is the measure of the maximum amount of [14C]MK-5475 in the plasma after the dose is given. | At designated time points (Up to ~ 23 days) |
| Half-life t1/2 | T1/2 is the time required for [14C]MK-5475 concentration in the plasma to decrease by 50%. | At designated time points (Up to ~ 23 days) |
| Time to Maximum Plasma Concentration (Tmax), | Tmax is a measure of the time to reach the maximum concentration in the plasma after the [14C]MK-5475 dose. | At designated time points (Up to ~ 23 days) |
| Apparent Total Clearance (CL; MK-5475 only) | CL is defined as apparent total clearance of [14C]MK-5475 from plasma after IV administration | At designated time points (Up to ~ 23 days) |
| Apparent Volume of Distribution (Vz; MK-5475 only) | Vz is defined as apparent volume of distribution of [14C]MK-5475 during terminal phase after IV administration. | At designated time points (Up to ~ 23 days) |
| AUC0-infinity Plasma [14C]MK-5475/Total Radioactivity Ratio | AUC time zero to infinity (0-∞) of [14C]MK-5475 in plasma/AUC0-∞ of total radioactivity in plasma. | At designated time points (Up to ~ 23 days) |
| Number of Participants Who Discontinue Study Due to an AE |
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study due to an AE will be reported. |
| Up to ~ 30 days |