NCT00874237

Staccato Loxapine Thorough QT/QTc Study

Thorough QT/QTc Study of Staccato® Loxapine 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

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.

Conditions

• Thorough QT/QTc Study

Interventions

Type	Name	Description
DRUG	Inhaled loxapine	Inhaled Staccato Loxapine 10 mg single dose
DRUG	Inhaled placebo	Inhaled Staccato placebo single dose
DRUG	Oral moxifloxacin	Oral moxifloxacin 400 mg
DRUG	Oral placebo	Oral placebo similar in appearance to moxifloxacin 400 mg

Timeline

• Start date: 2009-04-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2009-04-02
• Last updated: 2019-10-30
• Results posted: 2019-10-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study