Staccato Loxapine Thorough QT/QTc Study

Thorough QT/QTc Study of Staccato® Loxapine for Inhalation in Healthy Volunteers

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.

Primary Objective: To assess the maximum effect of Staccato Loxapine on cardiac repolarization (QTc interval duration) at the anticipated maximum clinical dose compared to placebo in healthy volunteers.

Secondary Objective: To assess the QTc versus loxapine concentration relationship following treatment with Staccato Loxapine in healthy volunteers.

Inclusion Criteria:

• Subjects who are in good general health and agree to use a medically acceptable and effective birth control method throughout the study.

Exclusion Criteria:

• Subjects who have taken prescription or nonprescription medication within 5 days of treatment,
• Subjects who have had an acute illness within the last 5 days of treatment,
• Subjects who are smokers, OR
• Subjects who have an ECG abnormality at baseline.