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| ID | Type | Description | Link |
|---|---|---|---|
| MK-1084-006 | Other Identifier | MSD |
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The purpose of this study is to learn what happens to calderasib in a healthy person's body over time and how it is cleared from the body.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carbon-14 radiolabeled [14C] MK-1084 | Experimental | Participants receive single oral dose of calderasib on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]Calderasib | Drug | Oral administration |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of plasma Calderasib | Bood samples will be collected to determine the AUC0-inf of calderasib in plasma. | Predose and at designated timepoints up to Day 15 |
| Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of plasma Calderasib | Blood samples will be collected to determine the AUC0-last of calderasib in plasma. | Predose and at designated timepoints up to Day 15 |
| Area Under the Concentration-Time Curve from 0 to 24 hours (AUC0-24) of plasma Calderasib | Blood samples will be collected to determine the AUC0-24 of plasma calderasib in plasma. | Predose and at designated timepoints up to Day 15 |
| Maximum Concentration (Cmax) of plasma Calderasib | Blood samples will be collected to determine the Cmax of calderasib in plasma. | Predose and at designated timepoints up to Day 15 |
| Concentration at 24 hours postdose (C24) of plasma Calderasib | Blood samples will be collected to determine the C24 of calderasib in plasma. | Predose and at designated timepoints up to Day 15 |
| Time to Reach Maximum Concentration (Tmax) of plasma Calderasib | Blood samples will be collected to determine the Tmax of calderasib in plasma. | Predose and at designated timepoints up to Day 15 |
| Apparent Half Life (t½) of plasma Calderasib |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing an Adverse Event (AE) | An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study treatment. For each arm, the number of participants experiencing an AE will be assessed. |
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Inclusion Criteria:
Key inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The key exclusion criteria include but are not limited to the following:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fortea CRU Madison (Site 0001) | Madison | Wisconsin | 53704 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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Blood samples will be collected to determine the t1/2 of calderasib in plasma. |
| Predose and at designated timepoints up to Day 15 |
| Apparent Total Clearance (CL/F) of plasma Calderasib | Blood samples will be collected to determine the CL/F of calderasib in plasma. | Predose and at designated timepoints up to Day 15 |
| Apparent Volume of Distribution during the Terminal Elimination Phase (Vz/F) of plasma Calderasib | Blood samples will be collected to determine the Vz/F of calderasib in plasma. | Predose and at designated timepoints up to Day 15 |
| AUC0-inf/Total Radioactivity Ratio of plasma Calderasib | Blood samples will be collected to determine the AUC0-inf/Total Radioactivity Ratio of calderasib in plasma. | Predose and at designated timepoints up to Day 15 |
| Amount Excreted in the Urine (Aeu) of Calderasib | Urine samples will be collected to determine the Aeu of calderasib | Predose and at designated timepoints up to Day 15 |
| Cumulative Aeu of Calderasib | Urine samples will be collected to determine the cumulative Ae of calderasib. | Predose and at designated timepoints up to Day 15 |
| Percentage Excreted in the Urine (feu) of Calderasib | Urine samples will be collected to determine the feu of calderasib. | Predose and at designated timepoints up to Day 15 |
| Cumulative feu of Calderasib | Urine samples will be collected to determine the cumulative feu of calderasib. | Predose and at designated timepoints up to Day 15 |
| Amount Excreted in the Feces (Aef) of Calderasib | Feces samples will be collected to determine the Aef of calderasib. | Predose and at designated timepoints up to Day 15 |
| Cumulative Aef of Calderasib | Feces samples will be collected to determine the cumulative Aef of calderasib. | Predose and at designated timepoints up to Day 15 |
| Percentage Excreted in the Feces (fef) of Calderasib | Feces samples will be collected to determine the fef of calderasib. | Predose and at designated timepoints up to Day 15 |
| Cumulative fef of Calderasib | Feces samples will be collected to determine the cumulative fef of calderasib. | Predose and at designated timepoints up to Day 15 |
| Metabolites in Plasma of Calderasib | Blood samples will be collected to determine the metabolites of calderasib. | Predose and at designated timepoints up to Day 15 |
| Metabolites in Urine of Calderasib | Urine samples will be collected to determine the metabolites of calderasib. | Predose and at designated timepoints up to Day 15 |
| Metabolites in Feces of Calderasib | Feces samples will be collected to determine the metabolites of calderasib. | Predose and at designated timepoints up to Day 15 |
| Up to ~ 28 days |
| Number of Participants Discontinuing Study Treatment due to an AE | An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study treatment. For each arm, the number of participants experiencing an AE will be assessed. | Up to ~ 28 days |