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NCT01780259
A Single-Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of Intranasally Administered Esketamine in Healthy Subjects
Phase 1 trial testing Esketamine in Healthy in 58 participants. Completed in 1 May 2013.
1 May 2013
Quick facts
| Lead sponsor | Janssen Research & Development, LLC |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 58 |
| Start date | 1 December 2012 |
| Primary completion | 1 May 2013 |
| Estimated completion | 1 May 2013 |
| Sites | 1 location across Belgium |
Drugs / interventions tested
- Esketamine (ESKETAMINE) — full drug profile →
- Placebo
- Triazolam — full drug profile →
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Janssen Research & Development, LLC — full company profile →
Who can join
Adults 18 to 55, any sex, with Healthy. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Maximum plasma concentration during a dosing interval (Cmax) of esketamine
Time frame: Predose, 7 minutes, 12 minutes, 22 minutes, 32 minutes, 40 minutes, 50 minutes, 1 hour, 1.25 hours, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 9 hours, 12 hours, 18 hours, 24 hours -
Time to reach the maximum plasma concentration (tmax) of esketamine
Time frame: Predose, 7 minutes, 12 minutes, 22 minutes, 32 minutes, 40 minutes, 50 minutes, 1 hour, 1.25 hours, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 9 hours, 12 hours, 18 hours, 24 hours -
Area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration (AUClast) of esketamine
Time frame: Predose, 7 minutes, 12 minutes, 22 minutes, 32 minutes, 40 minutes, 50 minutes, 1 hour, 1.25 hours, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 9 hours, 12 hours, 18 hours, 24 hours
Sponsor's own description
The primary purpose of the study is to evaluate the pharmacokinetics (what the body does to the medication) of intranasally (through the nose) administered esketamine in healthy participants.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Population Pharmacokinetics of Esketamine Nasal Spray and its Metabolite Noresketamine in Healthy Subjects and Patients with Treatment-Resistant Depression.
Perez-Ruixo C, Rossenu S, Zannikos P, Nandy P, et al · · 2021 · cited 41× · PMID 33128208 · DOI 10.1007/s40262-020-00953-4
Verify or expand the search:
- PubMed search for NCT01780259
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT07179913 — The Improvement of Low-dose Esketamine on Postoperative Depression in Patients Undergoing Bariatric Surgery With Preoper · Phase 4 · not yet recruiting
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Currently open trials in the same condition.
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Other Janssen Research & Development, LLC trials
Trials by the same sponsor.
- NCT07518186 — A Study Comparing JNJ-79635322 and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma · Phase 3 · not yet recruiting
- NCT07309445 — A Study to Assess Real-World Use and Outcomes of TAR-200 for Participants With Non-Muscle Invasive Bladder Cancer (NMIBC · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01780259 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Janssen Research & Development, LLC
- Last refreshed: 6 August 2013
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01780259.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing