The purpose of this study is to determine the relative amounts of radioactivity excreted in urine and feces following a single oral dose of \[14C\]-OPC-167832 in healthy male participants.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Oral suspension
Celerion, Inc
Lincoln, Nebraska, United States
Cumulative Amount (Microgram Equivalents) of OPC-167832 Excreted in Urine (Ae,u)
Time frame: Up to Day 31
Cumulative Amount (Microgram Equivalents) of OPC-167832 Excreted in Feces (Ae,f)
Time frame: Up to Day 31
Percentage of OPC-167832 Dose Excreted in Urine (%fe,u)
Time frame: Up to Day 31
Percentage of OPC-167832 Dose Excreted in Feces (%fe,f)
Time frame: Up to Day 31
Maximum (peak) Concentration (Cmax) of Total Radioactivity in Plasma and Whole Blood
Time frame: Up to Day 31
Time to Maximum (Peak) Concentration (Tmax) of Total Radioactivity in Plasma and Whole Blood
Time frame: Up to Day 31
Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Observable Concentration (AUCt) of Total Radioactivity in Plasma and Whole Blood
Time frame: Up to Day 31
Area Under the Concentration-Time Curve From Time Zero to infinity (AUCinfinity) of Total Radioactivity in Plasma and Whole Blood
Time frame: Up to Day 31
Terminal-phase Elimination Half-life (t1/2,z) of Total Radioactivity in Plasma and Whole Blood
Time frame: Up to Day 31
Hemocrit Blood to Plasma Concentration Adjusted Ratio
Time frame: Up to Day 31
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Percentage of Metabolite in Plasma With an AUC > 10% of the AUC of Plasma Radioactivity Based on Radiometric Profiling
Time frame: Up to Day 31
Cmax of OPC-167832
Time frame: Up to Day 31
Tmax of OPC-167832
Time frame: Up to Day 31
AUCt of OPC-167832
Time frame: Up to Day 31
AUCinfinity of OPC-167832
Time frame: Up to Day 31
t1/2,z of OPC-167832
Time frame: Up to Day 31
Apparent Clearance (CL/F) of Drug from Plasma Following Extravascular Administration of OPC-167832
Time frame: Up to Day 31
Percent Radioactivity Excreted in Urine and Feces as Parent and Identified Metabolites From Profiling data
Time frame: Up to Day 31
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to Day 31
Number of Participants With Potentially Clinically Relevant Changes in Clinical Laboratory Tests
Time frame: Up to Day 31
Number of Participants With Potentially Clinically Relevant Changes in Vital Signs
Time frame: Up to Day 31
Number of Participants With Potentially Clinically Relevant Changes in Physical Examinations
Time frame: Up to Day 31
Number of Participants With Potentially Clinically Relevant Changes in Electrocardiogram (ECG) Parameters
Time frame: Up to Day 31