To evaluate the metabolism and excretion of \[14C\]-CC-122 in healthy male subjects
This is a single-center, open-label study to evaluate the metabolism and excretion of \[14C\]-CC-122 following a single oral dose of \[14C\]-CC-122 in healthy male subjects. It is planned for 6 subjects to be enrolled; each subject will participate in a screening phase, a baseline phase, a treatment phase, and a follow up phone call. Blood, urine and fecal samples will be collected for analyses.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Enrollment
6
3mg \[14C\]-CC-122 will be administered as a single dose
Covance Clinical Research Unit Inc
Madison, Wisconsin, United States
Total [14C]-radioactivity in biological matrices-Pharmacokinetics (PK)
Biological matrices (whole blood, plasma, urine and feces) will be collected and analyzed for total \[14C\]-radioactivity
Time frame: Up to 12 days
Cumulative excretion of total [14C]-radioactivity in urine and feces (PK)
Urine and feces will be collected and analyzed for measurement of \[14C\]-radioactivity
Time frame: Up to 12 days
Total [14C]-radioactivity whole blood-to-plasma ratios: PK
Blood samples will be collected and analyzed for measurement of \[14C\]-radioactivity
Time frame: Up to 8 days
Metabolite profiling/characterization in select biological matrices-PK
Biological matrices (plasma, urine, and fecal samples) will be collected and select samples will undergo metabolite profiling/characterization
Time frame: Up to 12 dyas
Peak (maximum) plasma concentration (Cmax) for total [14C]-radioactivity, [14C]-CC-122, and [14C]-metabolite(s), as appropriate PK
Blood samples will be collected and analyzed; Maximum observed plasma or whole blood concentration for up to 168 hours postdose will be calculated and reported as appropriate
Time frame: Up to 12 days
Area under the plasma concentration-time curve (AUC) for total [14C]-radioactivity, [14C]-CC-122, and [14C]-metabolite(s), as appropriate
Blood samples will be collected and analyzed; Area under the concentration-time curve from time zero up to 168 hours postdose will be calculated and reported as appropriate
Time frame: Up to 12 days
Time to maximum plasma concentration (Tmax) for total [14C]-radioactivity, [14C]-CC-122, and [14C]-metabolite(s), as appropriate
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Blood samples will be collected and analyzed; Time to reach the observed maximum (peak) concentration will be calculated and reported as appropriate.
Time frame: Up to 12 days
Terminal elimination half-life (t1/2) for total [14C]-radioactivity, [14C]-CC-122, and [14C]-metabolite(s), as appropriate
Blood samples will be collected and analyzed; Terminal half-life will be calculated and reported as appropriate
Time frame: Up to 12 days
The incidence, type, severity of adverse events (AE)
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
Time frame: Up to 28 days following dose; AEs will be collected and recorded from the time the subjects signs Informed Consent throughthe 28 day period following the of last dose of study drug