NCT00543062

Staccato Prochlorperazine Thorough QT/QTc

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Alexza Pharmaceuticals, Inc. · Unknown
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cardiotoxicity

Interventions

Type	Name	Description
DRUG	Inhaled placebo	Inhaled Staccato placebo (0 mg)
DRUG	Oral placebo	Oral placebo (identical to 400 mg moxifloxacin)
DRUG	Inhaled prochlorperazine 5 mg	Staccato prochlorperazine 5 mg, single dose
DRUG	Inhaled prochlorperazine 10 mg	Inhaled prochlorperazine 10 mg, single dose
DRUG	Oral moxifloxacin	Oral moxifloxacin 400 mg, si/ngle dose

Timeline

• Start date: 2007-10-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2007-10-12
• Last updated: 2019-03-11
• Results posted: 2019-03-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study