Conditions: Cardiotoxicity
Keywords: Inhaled prochlorperazine, Thorough Qt/QTc,
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 48
Healthy volunteers: yes

Brief summary:
To assess the safety of Staccato Prochlorperazine on cardiac repolarization (QTc interval duration) at 2 dose levels compared to placebo in healthy volunteers.

Detailed description:
The planned study is a single dose, double-blind, double-dummy, active and placebo controlled, randomized, 4-period cross-over study investigating investigating 2 doses levels of Staccato Prochlorperazine, a positive control with known QT/QTc prolongation (oral moxifloxacin), and placebo.

Arms:
arm 1: Treatment Sequence ABCD where Treatment: A = Inhaled prochlorperazine (10 mg) + oral placebo, B = Inhaled prochlorperazine (5 mg) + oral placebo, C = Inhaled placebo + oral placebo, D = Inhaled placebo + oral moxifloxacin 400 mg arm 2: Treatment Sequence BDAC where Treatment: A = Inhaled prochlorperazine (10 mg) + oral placebo, B = Inhaled prochlorperazine (5 mg) + oral placebo, C = Inhaled placebo + oral placebo, D = Inhaled placebo + oral moxifloxacin 400 mg arm 3: Treatment Sequence CABD where Treatment: A = Inhaled prochlorperazine (10 mg) + oral placebo, B = Inhaled prochlorperazine (5 mg) + oral placebo, C = Inhaled placebo + oral placebo, D = Inhaled placebo + oral moxifloxacin 400 mg arm 4: Treatment Sequence DCBA where Treatment: A = Inhaled prochlorperazine (10 mg) + oral placebo, B = Inhaled prochlorperazine (5 mg) + oral placebo, C = Inhaled placebo + oral placebo, D = Inhaled placebo + oral moxifloxacin 400 mg

Interventions: intervention 1: Inhaled placebo intervention 2: Oral placebo intervention 3: Inhaled prochlorperazine 5 mg intervention 4: Inhaled prochlorperazine 10 mg intervention 5: Oral moxifloxacin
Intervention descriptions: intervention 1: Inhaled Staccato placebo (0 mg) intervention 2: Oral placebo (identical to 400 mg moxifloxacin) intervention 3: Staccato prochlorperazine 5 mg, single dose intervention 4: Inhaled prochlorperazine 10 mg, single dose intervention 5: Oral moxifloxacin 400 mg, si/ngle dose

Protocol document: