drugset / Trial / NCT04182958

A Phase I, Open-Label Trial to Assess the Absorption, Metabolism, and Excretion of (14C)-OPC-61815 in Healthy Male Japanese Subjects

NCT04182958

Phase 1 Completed 8 enrolled Otsuka Pharmaceutical Co., Ltd.
NaSingle-groupOpen-labelTreatment

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

Timeline

Start
2019-11-25
Primary completion
2019-12-19
Completion
2019-12-19

Drugs

EvaluationDrugModalityDoseRoute
Subject OPC-61815 Unknown Intravenous

Indications

No indication recorded.