A Study to Assess the Pharmacokinetics, Safety, and Tolerability of Intranasally Administered Esketamine in Healthy Participants

Phase 1 Completed 58 enrolled Janssen Research & Development, LLC

RandomizedCrossoverOpen-labelTreatment

Summary

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.

Timeline

Start: 2012-12
Primary completion: 2013-05
Completion: 2013-05

Publications

Perez-Ruixo C, Rossenu S, Zannikos P, Nandy P, Singh J, Drevets WC, Perez-Ruixo JJ. Population Pharmacokinetics of Esketamine Nasal Spray and its Metabolite Noresketamine in Healthy Subjects and Patients with Treatment-Resistant Depression. Clin Pharmacokinet. 2021 Apr;60(4):501-516. doi: 10.1007/s40262-020-00953-4. Epub 2020 Oct 31.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Esketamine	Other / unclassified	28 mg	Intranasal
Subject	Esketamine	Other / unclassified	56 mg	Intranasal
Subject	Esketamine	Other / unclassified	84 mg	Intranasal
Subject	Esketamine	Other / unclassified	112 mg	Intranasal
Background	Triazolam	Small molecule	0.25 mg	Oral

Indications

No indication recorded.