Staccato Loxapine Single Dose PK

Phase 1 Completed 50 enrolled Alexza Pharmaceuticals, Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The objective of this study was to assess the safety, tolerability and pharmacokinetics of a single inhaled dose of (administered in 1 or 2 puffs) Staccato Loxapine in healthy volunteers.

Timeline

Start: 2005-09
Primary completion: 2005-11
Completion: 2005-11

Publications

Results Spyker DA, Munzar P, Cassella JV. Pharmacokinetics of loxapine following inhalation of a thermally generated aerosol in healthy volunteers. J Clin Pharmacol. 2010 Feb;50(2):169-79. doi: 10.1177/0091270009347866. Epub 2009 Nov 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	loxapine	Small molecule	0.625 mg	Inhaled
Subject	loxapine	Small molecule	1.25 mg	Inhaled
Subject	loxapine	Small molecule	2.5 mg	Inhaled
Subject	loxapine	Small molecule	5 mg	Inhaled
Subject	loxapine	Small molecule	10 mg	Inhaled

Staccato Loxapine Single Dose PK

Summary

Timeline

Publications

Drugs

Indications