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| ID | Type | Description | Link |
|---|---|---|---|
| MK-1084-010 | Other Identifier | MSD |
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The goal of this study is to learn what happens to calderasib levels in a person's body over time. Researchers will measure what happens to calderasib levels in the body when it is given to people with moderate or severe renal impairment (RI) (meaning the kidneys do not work properly) as compared to people who are in good health. Researchers also want to learn about the safety of calderasib when it is given to people with RI and if people with RI can tolerate it.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Panel A: Severe RI | Experimental | Participants with severe RI will be administered a single oral dose of calderasib on Day 1 under fasting conditions. |
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| Panel B: Moderate RI | Experimental | Participants with moderate RI will be administered a single oral dose of calderasib on Day 1 under fasting conditions. |
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| Panel C: Healthy | Experimental | Healthy participants will be administered a single oral dose of calderasib on Day 1 under fasting conditions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calderasib | Drug | Oral tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of calderasib | Blood samples will be collected to determine the AUC0-inf of calderasib. | At designated timepoints (up to approximately 2 days postdose) |
| Area Under the Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of calderasib | Blood samples will be collected to determine the AUC0-last of calderasib. | At designated timepoints (up to approximately 2 days postdose) |
| Area Under the Concentration-Time Curve from Time 0 to 24 Hours (AUC0-24) of calderasib | Blood samples will be collected to determine the AUC0-24 of calderasib. | At designated timepoints (up to 24 hours postdose) |
| Plasma Concentration of calderasib at 24 Hours Postdose (C24) | Blood samples will be collected to determine the C24 of calderasib. | At designated timepoints (up to 24 hours postdose) |
| Maximum Plasma Concentration (Cmax) of calderasib | Blood samples will be collected to determine the Cmax of calderasib. | At designated timepoints (up to approximately 2 days postdose) |
| Time to Maximum Plasma Concentration (Tmax) of calderasib | Blood samples will be collected to determine the Tmax of calderasib. | At designated timepoints (up to approximately 2 days postdose) |
| Apparent Terminal Half-life (t1/2) of calderasib |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experience an Adverse Event | An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. The number of participants who experience an adverse event will be reported. | Up to approximately 2 weeks |
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Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
All participants:
- Has a BMI ≥18.0 and ≤40.0 kg/m^2
Participants with severe or moderate RI:
Participants with normal renal function:
- Is medically healthy
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
All participants:
Participants with severe or moderate RI:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orlando Clinical Research Center ( Site 0002) | Orlando | Florida | 32809 | United States | ||
| Research by Design ( Site 0001) |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Blood samples will be collected to determine the t1/2 of calderasib. |
| At designated timepoints (up to approximately 2 days postdose) |
| Apparent Clearance (CL/F) of calderasib | Blood samples will be collected to determine the CL/F of calderasib. | At designated timepoints (up to approximately 2 days postdose) |
| Apparent Volume of Distribution During Terminal Phase (Vz/F) of calderasib | Blood samples will be collected to determine the Vz/F of calderasib. | At designated timepoints (up to approximately 2 days postdose) |
| Number of Participants Who Discontinue From the Study Due to an Adverse Event | An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. The number of participants who discontinue from the study due to an adverse event will be reported. | Up to approximately 2 weeks |
| Total Amount of calderasib Excreted Unchanged in Urine (Ae) | Urine samples will be collected to determine the Ae of calderasib. | At designated timepoints (up to approximately 1 day postdose) |
| Total Amount of calderasib Excreted Unchanged in Urine From 0 to 24 Hours (Ae0-24) | Urine samples will be collected to determine the Ae0-24 of calderasib. | At designated timepoints (up to 24 hours postdose) |
| Fraction of calderasib Excreted Unchanged in Urine (fe) | Urine samples will be collected to determine the fe of calderasib. | At designated timepoints (up to approximately 1 day postdose) |
| Renal Clearance (CLr) of calderasib | Urine samples will be collected to determine the CLr of calderasib. | At designated timepoints (up to approximately 1 day postdose) |
| Chicago |
| Illinois |
| 60643 |
| United States |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |