The primary objective of this study is to perform mass balance following a single oral dose of \[14C\]CCX168 in healthy adult male participants.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
6
Administered orally.
Covance Clinical Research Unit, Inc.
Madison, Wisconsin, United States
Cumulative Percentage of the Administered Dose of [14C]CCX168 Recovered in Urine
Time frame: Up to Day 15
Cumulative Percentage of the Administered Dose of [14C]CCX168 Recovered in Feces
Time frame: Up to Day 15
Maximum Observed Concentration (Cmax) of Total Radioactivity in Plasma and Whole Blood
Time frame: Up to Day 10
Time of Occurrence of Maximum Observed Concentration (Tmax) of Total Radioactivity in Plasma and Whole Blood
Time frame: Up to Day 10
Elimination Rate Constant (λz) of Total Radioactivity in Plasma and Whole Blood
Time frame: Up to Day 10
Apparent Terminal Half-life (t½z) of Total Radioactivity in Plasma and Whole Blood
Time frame: Up to Day 10
Apparent Total Clearance (CL/F) of Total Radioactivity in Plasma and Whole Blood
Time frame: Up to Day 10
Apparent Volume of Distribution (Vz/F) of Total Radioactivity in Plasma and Whole Blood
Time frame: Up to Day 10
Area Under the Concentration-Time Curve from Time 0 to Time t (AUC0-t) of Total Radioactivity in Plasma and Whole Blood
Time frame: Up to Day 10
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUCinf) of Total Radioactivity in Plasma and Whole Blood
Time frame: Up to Day 10
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Area Under the Concentration-Time Curve from Time 0 to 24 Hours (AUC0-24) of Total Radioactivity in Plasma and Whole Blood
Time frame: Up to 24 hours
Cmax of CCX168 and Metabolites in Plasma
Time frame: Up to Day 10
Tmax of CCX168 and Metabolites in Plasma
Time frame: Up to Day 10
λz of CCX168 and Metabolites in Plasma
Time frame: Up to Day 10
t½z of CCX168 and Metabolites in Plasma
Time frame: Up to Day 10
CL/F of CCX168 and Metabolites in Plasma
Time frame: Up to Day 10
Vz/F of CCX168 and Metabolites in Plasma
Time frame: Up to Day 10
AUC0-t of CCX168 and Metabolites in Plasma
Time frame: Up to Day 10
AUCinf of CCX168 and Metabolites in Plasma
Time frame: Up to Day 10
AUC0-24 of CCX168 and Metabolites in Plasma
Time frame: Up to 24 hours
Percentage of Unchanged [14C]CCX168 Recovered in Urine, Feces, and Vomitus
Time frame: Up to Day 15
Percentage of [14C]-Metabolite Recovered in Urine, Feces, and Vomitus
Time frame: Up to Day 15
Amount of Unchanged [14C]CCX168 Recovered in Urine, Feces, and Vomitus (Auinf + Afinf + Avinf)
Time frame: Up to Day 15
Amount of [14C]-Metabolite Recovered in Urine, Feces, and Vomitus (Amxuinf + Amxfinf + Amxvinf)
Time frame: Up to Day 15
Renal Clearance (CLR) of [14C]CCX168
Time frame: Up to Day 15
Renal Clearance of [14C]-Metabolite (CLRmx)
Time frame: Up to Day 15
Number of Participants Experiencing Adverse Events (AEs)
Time frame: Up to Day 29
Number of Participants Experiencing Clinically Significant Changes in Laboratory Parameters
Time frame: Up to Day 29
Number of Participants Experiencing Clinically Significant Changes in Vital Sign Parameters
Time frame: Up to Day 29