A Study to Evaluate the Absolute Bioavailability of Intranasal and Oral Esketamine and the Effects of Clarithromycin on the Pharmacokinetics of Intranasal Esketamine in Healthy Participants

Phase 1 Completed 18 enrolled Janssen Research & Development, LLC

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of esketamine administered by the intranasal (administered through the nose) and oral routes and to evaluate the effects of clarithromycin on the pharmacokinetics of intranasally administered esketamine.

Timeline

Start: 2015-01
Primary completion: 2015-04
Completion: 2015-04

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	Clarithromycin	Small molecule	500 mg	—
Subject	Esketamine	Other / unclassified	28 mg	Intravenous
Subject	Esketamine	Other / unclassified	84 mg	Intravenous

Indications

No indication recorded.