The purpose of the study is to determine the absorption, metabolism, and excretion of \[14C\]-evobrutinib in healthy participants
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
6
Participants will receive a single, oral dose of evobrutinib under fasting conditions as a solution, which will contain \[14C\]-evobrutinib.
PRA Health Sciences
Groningen, Netherlands
Total Radioactivity Recovery Rate of Evobrutinib, Total Radioactivity and its Metabolites
Time frame: Pre-dose up to Day 35 post-dose
Percentage Excretion of Evobrutinib, Total Radioactivity and its Metabolites in Urine and Feces
Time frame: Pre-dose up to Day 35 post-dose
Renal Clearance of Evobrutinib, Total Radioactivity and its Metabolites
Time frame: Pre-dose up to Day 35 post-dose
Maximum Observed Plasma Concentration (Cmax) of Total [14C] Radioactivity (Evobrutinib and Metabolites)
Time frame: Pre-dose up to Day 35 post-dose
Time to Reach Maximum Plasma Concentration (Tmax) of Total [14C] Radioactivity (Evobrutinib and Metabolites)
Time frame: Pre-dose up to Day 35 post-dose
Terminal Elimination Half-Life (t1/2) of Total [14C] Radioactivity (Evobrutinib and Metabolites)
Time frame: Pre-dose up to Day 35 post-dose
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Total [14C] Radioactivity (Evobrutinib and Metabolites)
Time frame: Pre-dose up to Day 35 post-dose
Maximum Observed Plasma Concentration (Cmax) of Evobrutinib
Time frame: Pre-dose up to Day 35 post-dose
Time to Reach Maximum Plasma Concentration (Tmax) of Evobrutinib
Time frame: Pre-dose up to Day 35 post-dose
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Evobrutinib
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Time frame: Pre-dose up to Day 35 post-dose
Terminal Elimination Half-Life (t1/2) of Evobrutinib
Time frame: Pre-dose up to Day 35 post-dose
Apparent Volume of Distribution During Terminal Phase (Vz/f) of Evobrutinib
Time frame: Pre-dose up to Day 35 post-dose
Apparent Clearance (CL/f) of Evobrutinib
Time frame: Pre-dose up to Day 35 post-dose
Number of Participants with Clinically Significant Change From Baseline in Vital Signs, Laboratory Parameters and Electrocardiogram Findings
Number of participants with clinically significant abnormalities will be reported.
Time frame: From time of first dose to end of study participation approximately at Day 37
Occurrence of Treatment -emergent Adverse Events (TEAEs) and Serious TEAEs
Time frame: From time of first dose to end of study participation approximately at Day 37
Occurrence of Treatment -emergent Adverse Events (TEAEs) and Serious TEAEs by Severity
Time frame: From time of first dose to end of study participation approximately at Day 37