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NCT02674295 · ClinicalTrials.gov registry record · Phase 1
A Mass Balance Study With a Microtracer Dose of 14C-esketamine in Healthy Male Participants
A Phase 1 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT02674295: Completed Phase 1 study, sponsored by Janssen Research & Development.
NCT02674295 is a Phase 1 study that has completed, run by Janssen Research & Development. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02674295, a Phase 1 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study 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.
Primary Outcome
Collection of urine and feces for 7 days is considered appropriate to characterize the metabolic profile of esketamine. Accelerator mass spectrometry (AMS), an ultrasensitive technique particularly suited for detection of low levels of 14C, will be used to assess levels of the microtracer in whole blood, plasma, and excreta (urine, feces). Plasma, urine and feces selected samples with relatively high radioactive content will be analyzed for metabolic profiling and identification using ultra perf
Interventions
- DRUG Esketamine 50 mg
- DRUG Esketamine 20 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2016-03 |
| Est. Completion | 2016-08 |
| Phase | Phase 1 |
What the finished NCT02674295 record still lists
NCT02674295 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 2 interventions - of which Esketamine 50 mg is the first listed.
NCT02674295 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02674295 about?
NCT02674295 is a clinical study titled "A Mass Balance Study With a Microtracer Dose of 14C-esketamine in Healthy Male Participants". 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.
What is the current status of trial NCT02674295?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2016-03. Estimated completion is 2016-08.
What interventions are being tested in trial NCT02674295?
The interventions under investigation include: Esketamine 50 mg (DRUG), Esketamine 20 mg (DRUG).
Who is sponsoring clinical trial NCT02674295?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02674295's enrollment target sits among peer trials
8 1959th of 2000 higher than 29 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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