Pharmacokinetic, Safety, and Tolerability Study of Intranasally Administered Esketamine in Elderly and and Healthy Younger Adult Participants

Phase 1 Completed 16 enrolled Janssen Research & Development, LLC

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to compare the pharmacokinetics, safety, and tolerability of intranasally administered esketamine in elderly participants (greater than equal to \[\>=\] 75 years of age) and younger healthy adult participants (18 to 55 years of age, inclusive).

Timeline

Start: 2014-12
Primary completion: 2015-01
Completion: 2015-01

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	84 mg	Intranasal

Indications

No indication recorded.