Staccato Loxapine Thorough QT/QTc Study

Phase 1 Completed 48 enrolled Nova Pneuma Inc. Covance · collab

RandomizedCrossoverQuadruple-blindTreatment

Summary

The purpose of the present Phase 1 study was to assess the cardiac safety of Staccato Loxapine administered to healthy volunteers in a 3 period crossover study.

Timeline

Start: 2009-04
Primary completion: 2009-06
Completion: 2009-06

Publications

Results Spyker DA, Voloshko P, Heyman ER, Cassella JV. Loxapine delivered as a thermally generated aerosol does not prolong QTc in a thorough QT/QTc study in healthy subjects. J Clin Pharmacol. 2014 Jun;54(6):665-74. doi: 10.1002/jcph.257. Epub 2014 Jan 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Moxifloxacin	Small molecule	400 mg	Oral
Subject	loxapine	Small molecule	10 mg	Inhaled

Indications

No indication recorded.