This is a single-center, open-label study to characterize the biotransformation and excretion of \[14C\]-CC-220 in healthy male subjects. Each subject will participate in screening, a treatment phase (including baseline), and a follow-up phone call. Subjects will be screened for eligibility. Subjects who have met all inclusion criteria and none of the exclusion criteria at screening will return to the study site on Day -1, and will be domiciled at the study site from Day -1 to Day 10. On Day 1, subjects will receive a single oral dose of 1 mg \[14C\]-CC-220 under fasted conditions. Blood, urine, and fecal samples will be collected throughout the study for pharmacokinetic (PK; inclusive of metabolite profiling / characterization), mass balance, and/or clinical laboratory assessments. Safety will be monitored throughout the study. Subjects will be discharged from the study site on Day 10 following completion of the scheduled study procedures and satisfactory safety review. Subjects will participate in a follow-up phone call within 5 to 7 days following discharge.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
1mg \[14C\]-CC-220 will be administered as a single dose
Single dose of \[14C\]-CC-220 will contain approximately 1.4 μCi of radioactivity
Covance Clinical Research Unit
Madison, Wisconsin, United States
Pharmacokinetics -Total [14C]-Radioactivity (RA)
Total \[14C\]-RA in whole blood, plasma, urine, and feces (and vomit, if applicable) will be measured via AMS.
Time frame: Up to approximately Day 10
Pharmacokinetics - Cumulative excretion of total [14C]-RA
Total RA recovery will be computed as the sum of the cumulative excretion (as % dose) in urine and feces (and vomit, if applicable).
Time frame: Up to approximately Day 10
Pharmacokinetics - Total [14C]-RA whole blood-to-plasma
Total \[14C\]-RA in whole blood and plasma will be converted to ngEq/mL concentration of \[14C\]-CC-220 based on specific activity of the dose.
Time frame: Up to approximately Day 10
Pharmacokinetics - metabolite profiling/characterization
Percentage of the administered dose attributed to CC-220 and metabolite(s), and the RA of \[14C\]-CC-220 and metabolite(s), as appropriate, will be estimated.
Time frame: Up to approximately Day 10
Pharmacokinetics -Cmax
Observed maximum plasma concentration, provided sufficient data available
Time frame: Up to approximately Day 10
Pharmacokinetics -AUC
Area under the concentration-time curve, provided sufficient data available
Time frame: Up to approximately Day 10
Pharmacokinetics -Tmax
Time to Cmax, provided sufficient data available
Time frame: Up to approximately Day 10
Pharmacokinetics -t1/2
Terminal elimination half-life, provided sufficient data available
Time frame: Up to approximately Day 10
Adverse Events (AEs)
Number of participants with adverse event
Time frame: From enrollment until at least 28 days after completion of study treatment
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