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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
34
Oral tablet
Orlando Clinical Research Center ( Site 0002)
Orlando, Florida, United States
Research by Design ( Site 0001)
Chicago, Illinois, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At designated timepoints (up to approximately 2 days postdose)
Apparent Terminal Half-life (t1/2) of calderasib
Blood samples will be collected to determine the t1/2 of calderasib.
Time frame: At designated timepoints (up to approximately 2 days postdose)
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Apparent Clearance (CL/F) of calderasib
Blood samples will be collected to determine the CL/F of calderasib.
Time frame: 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.
Time frame: At designated timepoints (up to approximately 2 days postdose)
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.
Time frame: Up to approximately 2 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At designated timepoints (up to approximately 1 day postdose)