This is a clinical pharmacology study to characterize the biotransformation and excretion of \[14C\]CC-90001 and to evaluate the safety and tolerability of \[14C\]CC-90001 following a single oral dose of \[14C\]CC-90001 in healthy male subjects. Approximately 8 subjects will be enrolled into the study with a goal of 6 subjects being eligible for analysis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Oral
Covance Clinical Research Unit Inc
Madison, Wisconsin, United States
Pharmacokinetics - Total [14C]-RA
Total \[14C\]-Radioactivity (RA) in whole blood, plasma, urine, and feces) will be measured via Liquid scintillation counting (LSC)
Time frame: Up to approximately 216 hours post dose
Pharmacokinetics - Cumulative excretion of total [14C]-RA
The total recovery of radioactivity will be computed as the sum of the cumulative excretion (as % dose) in urine and feces
Time frame: Up to approximately 13 days
Pharmacokinetics - Total [14C]-RA whole blood-to-plasma ratios
Total \[14C\]-RA in whole blood and plasma will be converted to ngEq/mL concentration of \[14C\]CC-90001 based on specific activity of the dose. Equivalent concentration-time profiles will be determined.
Time frame: Up to approximately 216 hours post
Pharmacokinetics - metabolite profiling in plasma
The RA will be determined for CC-90001 and any identified metabolites in plasma. Metabolite profiling may use pooled time points.
Time frame: Up to approximately 216 hours post
Pharmacokinetics - metabolite profiling in urine and feces
Percentage of the administered dose, and the RA, will be determined for CC-90001 and any identified metabolites in urine and feces. Metabolite profiling may use pooled collection intervals.
Time frame: Up to approximately 13 days
Pharmacokinetics - Cmax
Observed maximum concentration of \[14C\]CC-90001 and for metabolites with sufficient measurable concentration
Time frame: Up to approximately 216 hours post
Pharmacokinetics - AUC
Area under the concentration-time curve of \[14C\]CC-90001 and for metabolites with sufficient measureable concentration
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Up to approximately 216 hours post
Pharmacokinetics - Tmax
Time to Cmax of \[14C\]CC-90001 and for metabolites with sufficient measureable concentration
Time frame: Up to approximately 216 hours post
Pharmacokinetics - t1/2
Terminal elimination half-life of \[14C\]CC-90001 and for metabolites with sufficient measureable concentration
Time frame: Up to approximately 216 hours post
Number of treatment-emergent adverse event related to CC-90001
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.
Time frame: From enrollment until at least 28 days after completion of study treatment