A Study to Assess the Pharmacokinetics of Intranasally Administered Esketamine in Healthy Japanese and Caucasian Volunteers

NCT01980303 ↗

Phase 1 Completed 29 enrolled Janssen Research & Development, LLC

RandomizedCrossoverOpen-labelTreatment

Summary

The purpose of this Phase 1 study is to characterize the pharmacokinetic profile (what the body does to the medication) of esketamine when given by the intranasal route (through the nose) to healthy adult Japanese and Caucasian participants.

Timeline

Start: 2013-11
Primary completion: 2014-01
Completion: 2014-01

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	28 mg	Intranasal
Subject	Esketamine	Other / unclassified	56 mg	Intranasal
Subject	Esketamine	Other / unclassified	84 mg	Intranasal

Indications

No indication recorded.