Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2026-03-01 @ 6:02 AM
Study NCT ID:
NCT04182958
Status:
COMPLETED
Last Update Posted:
2021-10-06
First Post:
2019-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase I, Open-Label Trial to Assess the Absorption, Metabolism, and Excretion of (14C)-OPC-61815 in Healthy Male Japanese Subjects
Sponsor:
Otsuka Pharmaceutical Co., Ltd.
Organization:
Study Overview
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
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
* 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2019-001968-29 | EUDRACT_NUMBER | None | View |