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

NCT04182958 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2021-10-06

Study results available
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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

DRUG

(14C)-OPC-61815

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

Sponsors & Collaborators

  • Otsuka Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Takehisa Matsumaru, Mr · Otsuka Pharmaceutical Co., Ltd.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04182958 on ClinicalTrials.gov