The primary objective of the study is to achieve mass balance recovery of \[14C\]-radiolabel in urine and feces and to identify and quantify the main elimination pathways of E2027.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
E2027 oral capsule.
Covance Clinical Research Unit Inc.
Madison, Wisconsin, United States
Cumulative Percent of the Radiolabeled Dose of [14C]E2027 in Biological Matrices (Blood, Urine, Feces and Toilet Tissue)
Blood, urine, feces and toilet tissue samples will be collected at specific time points and will be analyzed for the amount of radiolabeled \[14C\]E2027.
Time frame: Up to 56 days
Maximum Concentration (Cmax) of Radiolabeled [14C]E2027, Non-Radiolabeled E2027 and Metabolites in Biological Matrices
Time frame: Pre-dose up to Day 56 post-dose
Time to Reach Maximum (Peak) Concentration (Tmax) of Radiolabeled [14C]E2027, Non-Radiolabeled E2027 and Metabolites in Biological Matrices
Time frame: Pre-dose up to Day 56 post-dose
Area Under the Concentration-Time Curve From Time Zero to 24 hours (AUC(0-24h)) of Radiolabeled [14C]E2027, Non-Radiolabeled E2027 and Metabolites in Biological Matrices
Time frame: Pre-dose up to Day 56 post-dose
Area Under the Concentration-Time Curve From Time Zero to Time of Last Measurable Concentration (AUC(0-t)) of Radiolabeled [14C]E2027, Non-Radiolabeled E2027 and Metabolites in Biological Matrices
Time frame: Pre-dose up to Day 56 post-dose
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC(0-inf)) of Radiolabeled [14C]E2027, Non-Radiolabeled E2027 and Metabolites in Biological Matrices
Time frame: Pre-dose up to Day 56 post-dose
Terminal Elimination Half-life (t1/2) of Radiolabeled [14C]E2027, Non-Radiolabeled E2027 and Metabolites in Biological Matrices
Time frame: Pre-dose up to Day 56 post-dose
Apparent Total Body Clearance (CL/F) of E2027 in Biological Matrices
Time frame: Pre-dose up to Day 56 post-dose
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Apparent Volume of Distribution (Vd/F) of E2027 in Biological Matrices
Time frame: Pre-dose up to Day 28 post-dose
Percent of AUC(0-inf) of Metabolite to E2027 in Biological Matrices
Time frame: Pre-dose up to Day 28 post-dose
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to 56 days post-dose
Number of Participants With Clinically Significant Abnormal Laboratory Values
Time frame: Up to 56 days post-dose
Number of Participants With Clinically Significant Abnormal Vital Sign Values
Time frame: Up to 56 days post-dose
Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Findings
Time frame: Up to 56 days post-dose
Number of Participants With Clinically Significant Abnormal Physical Examination Findings
Time frame: Baseline, Up to 56 days post-dose