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NCT02846519
Pharmacokinetic, Safety, and Tolerability Study of Intranasally Administered Esketamine in Healthy Han Chinese, Korean, Japanese, and Caucasian Participants and the Effects of Rifampin on the Pharmacokinetics of Intranasally Administered Esketamine
Phase 1 trial testing Esketamine in Healthy in 66 participants. Completed in 28 May 2016.
28 May 2016
Quick facts
| Lead sponsor | Janssen Research & Development, LLC |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 66 |
| Start date | 26 February 2016 |
| Primary completion | 28 May 2016 |
| Estimated completion | 28 May 2016 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Esketamine (ESKETAMINE) — full drug profile →
- Rifampin — full drug profile →
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Janssen Research & Development, LLC — full company profile →
Who can join
Adults 20 to 55, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to evaluate the pharmacokinetics of intranasally administered esketamine in healthy Han Chinese, Korean, Japanese, and Caucasian participants and to evaluate the effects of rifampin on the pharmacokinetics of intranasally administered esketamine in healthy Caucasian 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 NCT02846519
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Janssen Research & Development, LLC trials
Trials by the same sponsor.
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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 NCT02846519 (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: 27 April 2025
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/NCT02846519.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing