Ignite Creation Date:
2025-12-24 @ 2:20 PM
Ignite Modification Date:
2026-01-05 @ 9:21 AM
Study NCT ID:
NCT02674295
Status:
COMPLETED
Last Update Posted:
2025-02-03
First Post:
2016-02-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Mass Balance Study With a Microtracer Dose of 14C-esketamine in Healthy Male Participants
Sponsor:
Janssen Research & Development, LLC
Organization:
Study Overview
Official Title:
An Open-label, Single-dose Mass Balance Study With a Microtracer Dose of 14C-esketamine in Healthy Male Subjects
Status:
COMPLETED
Status Verified Date:
2025-01
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 metabolic disposition of radiolabeled esketamine administered by the oral and intravenous routes in healthy male participants.
Detailed Description:
This is a single-center, open-label (identity of study drug will be known to participant and study staff), single-dose, parallel-group study. The study consist of Screening Phase (Days -21 to -2), Open-label treatment Phase (Day -1 up to Day 8) and End of Study (9 to 13 days after last study assessment). The total duration of study from the Screening Phase through Follow-up, is 37-41 days. Participants will be assigned to 1 of the two groups (Cohort 1 and Cohort 2) during the treatment phase. The participants will be primarily evaluated to determine the metabolic disposition of radiolabeled esketamine administered by the oral and intravenous routes. Participants' safety will be monitored throughout the study.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|---|
| 54135419TRD1016 | OTHER | Janssen Research & Development, LLC | View |