Table 2.

Published studies on inhaled FGA loxapine in healthy subjects.

Authors	Year	Study Sample	Study Design	Number of Subject	Study Aims	Dose (mg/Day)	Main Findings
Spyker et al.	2010	Healthy subjects	Randomized, double-blind, placebo-controlled, dose escalation study	50	To determine the pharmacokinetic characteristics, safety, and tolerability of single doses of inhaled loxapine	0.625, 1.25, 2.5, 5.0, or 10 mg of loxapine or placebo	The inhalation of loxapine represented a safe and well-tolerated route for rapidly achieving therapeutic plasma concentrations
Spyker et al.	2014	Healthy subjects	randomized, placebo-controlled, double-blind crossover study	48	To evaluate effects of inhaled loxapine on the QTc interval	Inhaled loxapine 10 mg or inhaled placebo	No QTc prolongation was observed with the therapeutic dose of inhaled loxapine
Cassella et al.	2015	Healthy subjects	randomized, double-blind, active- and placebo-controlled, crossover, thorough QT study	60	To assessed the effect of two inhaled loxapine doses on cardiac repolarization as measured by QTc interval	inhaled loxapine (10 mg) 2 h apart+oral placebo, two doses of inhaled placebo+oral placebo, or two doses of inhaled placebo+oralmoxifloxacin (400 mg; positive control)	The two therapeutic doses of inhaled loxapine did not cause threshold QTc prolongation
Spyker et al.	2015	Healthy subjects	Randomized, double-blind, crossover study	22	Pharmacodynamic effects and safety of single-dose inhaled loxapine and IM lorazepam in combination versus each agent alone	lorazepam 1 mg IM, inhaled loxapine 10 mg, placebo IM (alone or combined)	Concomitant administration of inhaled loxapine and lorazepam in healthy volunteers showed no difference in its effect on respiration rate or pulse oximetry (primary endpoints) versus either drug alone