At a glance
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A Phase I, Open-Label Trial to Assess the Mass Balance and Pharmacokinetics of a Single Intravenous Administration of (14C)-OPC-61815 to Healthy Male Japanese Subjects
In Brief
A Phase 1 clinical trial evaluating (14C)-OPC-61815 for Healthy Adult Male. Completed, enrolled 8 participants across 1 site.
Detailed Summary
* 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 Details
Timeline
Interventions
On the morning of Day 1, all subjects will receive a single IV infusion of (14C) OPC-61815