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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

Completed Phase 1 Last updated 27 April 2025
What this trial tests

Phase 1 trial testing Esketamine in Healthy in 66 participants. Completed in 28 May 2016.

Timeline
26 February 2016
Primary endpoint
28 May 2016
28 May 2016

Quick facts

Lead sponsorJanssen Research & Development, LLC
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment66
Start date26 February 2016
Primary completion28 May 2016
Estimated completion28 May 2016
Sites1 location across United States

Drugs / interventions tested

Conditions studied

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):

  1. 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

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Other trials of Esketamine

Trials testing the same drug.

Other recruiting trials for Healthy

Currently open trials in the same condition.

Other Janssen Research & Development, LLC trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing