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

Healthy Adult Male Clinical Trial

Official title:
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

Status Completed

Clinical Trial 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

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Healthy Adult Male

Clinical Trial Details

NCT number	NCT04182958
Study type	Interventional
Source	Otsuka Pharmaceutical Co., Ltd.
Contact
Status	Completed
Phase	Phase 1
Start date	November 25, 2019
Completion date	December 19, 2019

View Details

See also
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