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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
8
Oral administration
Fortea CRU Madison (Site 0001)
Madison, Wisconsin, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Predose and at designated timepoints up to Day 15
Apparent Half Life (t½) of plasma Calderasib
Blood samples will be collected to determine the t1/2 of calderasib in plasma.
Time frame: Predose and at designated timepoints up to Day 15
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Apparent Total Clearance (CL/F) of plasma Calderasib
Blood samples will be collected to determine the CL/F of calderasib in plasma.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Predose and at designated timepoints up to Day 15
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.
Time frame: 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.
Time frame: Up to ~ 28 days