The study was designed to evaluate how CORT125134 is taken up, broken down and removed from the body when given as an oral capsule to healthy subjects.
The study was conducted to determine the recovery of \[14C\]-CORT125134 after the administration of a single oral dose of \[14C\]-CORT125134, to determine the routes and rate of elimination of \[14C\]-CORT125134 and associated radioactivity from the body, and to measure concentrations of radioactivity in the blood. Additional objectives of the study were to determine the chemical structure of each significant metabolite in plasma, urine and feces. Safety and tolerability were assessed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
9
Quotient Clinical
Nottingham, Nottinghamshire, United Kingdom
Amount of radioactivity eliminated in urine
Time frame: Day 1 pre-dose to Day 8 post-dose
Amount of radioactivity eliminated in feces
Time frame: Day 1 pre-dose to Day 8 post-dose
Amount of radioactivity eliminated in urine and feces
Time frame: Day 1 pre-dose to Day 8 post-dose
Cumulative amount of radioactivity eliminated in urine
Time frame: Day 1 pre-dose to Day 8 post-dose
Cumulative amount of radioactivity eliminated in feces
Time frame: Day 1 pre-dose to Day 8 post-dose
Cumulative amount of radioactivity eliminated in urine and feces
Time frame: Day 1 pre-dose to Day 8 post-dose
Pharmacokinetics (PK) of total radioactivity: lag time (tlag)
Time frame: Day 1 pre-dose to Day 8 post-dose
PK of total radioactivity: peak plasma concentration (Cmax)
Time frame: Day 1 pre-dose to Day 8 post-dose
PK of total radioactivity: time to reach maximum observed concentration (tmax)
Time frame: Day 1 pre-dose to Day 8 post-dose
PK of total radioactivity: area under the plasma concentration-time curve from time zero to time of last measurable concentration (AUClast)
Time frame: Day 1 pre-dose to Day 8 post-dose
PK of total radioactivity: area under the plasma concentration-time curve from time zero to infinity (AUCinf)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Day 1 pre-dose to Day 8 post-dose
PK of total radioactivity: area under the plasma concentration-time curve extrapolated from time t to infinity as a percentage of total AUC (%AUCextrap)
Time frame: Day 1 pre-dose to Day 8 post-dose
PK of total radioactivity: first-order elimination rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve (lambda-z)
Time frame: Day 1 pre-dose to Day 8 post-dose
PK of total radioactivity: elimination half-life (t1/2)
Time frame: Day 1 pre-dose to Day 8 post-dose
Metabolic profiling and structural identification in plasma, urine and feces
Time frame: Day 1 pre-dose to Day 8 post-dose
Hematology
Time frame: Screening, Day 1 pre-dose, Day 8
Clinical chemistry
Time frame: Screening, Day 1 pre-dose, Day 8
Urinalysis
Time frame: Screening, Day 1 pre-dose, Day 8
Blood pressure
Time frame: Screening, Day 1 pre-dose and 2 hours post-dose, Day 8
Heart rate
Time frame: Screening, Day 1 pre-dose and 2 hours post-dose, Day 8
Electrocardiogram
Time frame: Screening, Day 1 pre-dose and 2 hours post-dose, Day 8
Percentage of subjects with adverse events
Time frame: Screening to Day 28
Physical examination
Time frame: Screening and Day 8
Tlag of CORT125134
Time frame: Day 1 pre-dose to Day 8 post-dose
Cmax of CORT125134
Time frame: Day 1 pre-dose to Day 8 post-dose
Tmax of CORT125134
Time frame: Day 1 pre-dose to Day 8 post-dose
AUClast of CORT125134
Time frame: Day 1 pre-dose to Day 8 post-dose
%AUCextrap of CORT125134
Time frame: Day 1 pre-dose to Day 8 post-dose
AUCinf of CORT125134
Time frame: Day 1 pre-dose to Day 8 post-dose
Lambda-z of CORT125134
Time frame: Day 1 pre-dose to Day 8 post-dose
T1/2 of CORT125134
Time frame: Day 1 pre-dose to Day 8 post-dose
Mean Residence Time (MRT) of CORT125134
Time frame: Day 1 pre-dose to Day 8 post-dose
Apparent oral clearance (CL/F) of CORT125134
Time frame: Day 1 pre-dose to Day 8 post-dose
Apparent volume of distribution (Vz/F) of CORT125134
Time frame: Day 1 pre-dose to Day 8 post-dose
Number of metabolites >10% of circulating radioactivity in plasma
Time frame: Day 1 pre-dose to Day 8 post-dose
Number of metabolites >10% of the dose in urine
Time frame: Day 1 pre-dose to Day 8 post-dose
Number of metabolites >10% of the dose in feces
Time frame: Day 1 pre-dose to Day 8 post-dose