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| ID | Type | Description | Link |
|---|---|---|---|
| MK-1084-017 | Other Identifier | MSD |
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The purpose 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 participants with hepatic (liver) impairment and healthy participants. Researchers also want to learn about the safety of MK-1084 when it is given to people with hepatic impairment and if people with hepatic impairment can tolerate it.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calderasib | Experimental | All participants will receive a single oral dose of calderasib on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calderasib | Drug | Oral Tablet |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration Versus Time Curve from 0 to the Time of the Last Quantifiable Sample (AUC0-last) of Calderasib | Blood samples will be collected to determine the AUC0-last of calderasib in plasma. | At designated timepoints up to approximately 7 days post-dose |
| Area Under the Concentration Versus Time Curve from 0 to Infinity (AUC0-inf) of Calderasib | Blood samples will be collected to determine the AUC0-inf of calderasib in plasma. | At designated timepoints up to approximately 7 days post-dose |
| Area Under the Concentration Versus Time Curve from 0 to 24 hours post-dose (AUC0-24) of Calderasib | Blood samples will be collected to determine the AUC0-24 of calderasib in plasma. | Up to approximately 24 hours post-dose |
| Maximum Observed Drug Concentration (Cmax) of Calderasib | Blood samples will be collected to determine the Cmax of calderasib in plasma. | At designated timepoints up to approximately 7 days post-dose |
| Time to Maximum Observed Drug Concentration (Tmax) of Calderasib | Blood samples will be collected to determine the Tmax of calderasib in plasma. | At designated timepoints up to approximately 7 days post-dose |
| Apparent Terminal Half-life (t1/2) of Calderasib | Blood samples will be collected to determine the t1/2 of calderasib in plasma. | At designated timepoints up to approximately 7 days post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experience an Adverse Event (AE) | An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. The number of participants experiencing AEs will be reported. | Up to approximately 14 days |
| Number of Participants Who Discontinue Study Due to an AE |
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The main inclusion criteria include but are not limited to:
All participants:
Participants with hepatic impairment (HI):
Healthy volunteers:
The main exclusion criteria include but are not limited to:
All participants:
Participants with HI:
Healthy volunteers:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Toll Free Number | Contact | 1-888-577-8839 | Trialsites@msd.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Clinical Trials ( Site 0003) | Recruiting | Chandler | Arizona | 85225 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| Apparent Clearance (CL/F) of Calderasib |
Blood samples will be collected to determine the CL/F of calderasib in plasma. |
| At designated timepoints up to approximately 7 days post-dose |
| Apparent Volume of Distribution During Terminal Phase (Vz/F) of Calderasib | Blood samples will be collected to determine the Vz/F of calderasib in plasma. | At designated timepoints up to approximately 7 days post-dose |
An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. The number of participants discontinuing the study due to AEs will be reported. |
| Up to approximately 14 days |
| Orlando Clinical Research Center ( Site 0001) | Recruiting | Orlando | Florida | 32809 | United States |
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| The Texas Liver Institute ( Site 0002) | Recruiting | San Antonio | Texas | 78215 | United States |
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