* To determine the mass balance of totalradioactivity following a single IV infusionof (14C)-OPC-61815. * To determine routes and rates of elimination of total radioactivity following a single IV infusion of (14C)-OPC-61815 * To assess the PK of total radioactivity in plasma and whole blood following a single IV infusion of (14C)-OPC-61815 * To assess the PK of OPC-61815 free form and OPC-41061 in plasma following a single IV infusion of (14C)-OPC-61815
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
On the morning of Day 1, all subjects will receive a single IV infusion of (14C) OPC-61815
Covance Clinical Research Unit Ltd
Leeds, United Kingdom
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC∞) - Plasma OPC-61815 Free Form
Time frame: 48 hours after dose
Maximum Peak Concentration (Cmax) - Plasma OPC-61815 Free Form
Time frame: 48 hours after dose
Terminal-phase Elimination Half-life (t1/2,z) - Plasma OPC-61815 Free Form
Time frame: 48 hours after dose
AUC∞ - Plasma OPC-41061
Time frame: 48 hours after dose
Cmax - Plasma OPC-41061
Time frame: 48 hours after dose
t1/2,z - Plasma OPC-41061
Time frame: 48 hours after dose
AUC∞ - Plasma Total Radioactivity
Time frame: 168 hours after dose
Cmax - Plasma Total Radioactivity
Time frame: 168 hours after dose
t1/2,z - Plasma Total Radioactivity
Time frame: 168 hours after dose
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