Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-01 @ 2:37 AM
Study NCT ID:
NCT07314320
Status:
COMPLETED
Last Update Posted:
2026-01-02
First Post:
2025-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Detect Radioactivity of [14C]-OPC-167832 in Urine and Feces in Healthy Men
Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Organization:
Study Overview
Official Title:
A Phase 1, Open-Label, Single-Dose Trial to Evaluate the Mass Balance and Pharmacokinetics of [14C]-OPC-167832 Administered Orally in Healthy Male Subjects
Status:
COMPLETED
Status Verified Date:
2025-12
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:
The purpose of this study is to determine the relative amounts of radioactivity excreted in urine and feces following a single oral dose of \[14C\]-OPC-167832 in healthy male participants.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
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?: