NCT04182958

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Otsuka Pharmaceutical Co., Ltd. · Industry
• Sex: Male
• Age: 35 Years – 55 Years
• Healthy volunteers: Accepted

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

Conditions

• Healthy Adult Male

Interventions

Type	Name	Description
DRUG	(14C)-OPC-61815	On the morning of Day 1, all subjects will receive a single IV infusion of (14C) OPC-61815

Timeline

• Start date: 2019-11-25
• Primary completion: 2019-12-19
• Completion: 2019-12-19
• First posted: 2019-12-02
• Last updated: 2021-10-06
• Results posted: 2021-10-06

Locations

1 site across 1 country: United Kingdom