Conditions: Thorough QT/QTc Study
Keywords: Staccato loxapine QT/QTc healthy volunteers Thorough QT/QTc study ADASUVE inhaled loxapine
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 48
Healthy volunteers: yes

Brief 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.

Detailed description:
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.

Arms:
arm 1: Treatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg arm 2: Treatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg arm 3: Treatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg arm 4: Treatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg arm 5: Treatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg arm 6: Treatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg

Interventions: intervention 1: Inhaled loxapine intervention 2: Inhaled placebo intervention 3: Oral moxifloxacin intervention 4: Oral placebo
Intervention descriptions: intervention 1: Inhaled Staccato Loxapine 10 mg single dose intervention 2: Inhaled Staccato placebo single dose intervention 3: Oral moxifloxacin 400 mg intervention 4: Oral placebo similar in appearance to moxifloxacin 400 mg

Protocol document: