Staccato Loxapine Thorough QT/QTc Study

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

Outcome

Met primary endpoint

paper being less than 10 milliseconds at all 11 post-dose times. PMID 24375070 ↗

paper this is a negative finding and there is no apparent QT prolongation associated with the therapeutic dose of inhaled loxapine. PMID 24375070 ↗

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.