NCT00789360

Staccato Loxapine Pulmonary Safety in Healthy Volunteers

Pulmonary Safety of Repeat Doses of Staccato® Loxapine for Inhalation in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Alexza Pharmaceuticals, Inc. · Unknown
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The objective of this trial is to assess the pulmonary safety of 2 inhaled doses of Staccato Loxapine within a day.

Detailed description

The planned study is a multiple dose, double-blind, placebo-controlled, randomized, 2-sequence, 2-period crossover study investigating pulmonary safety in healthy volunteers.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Inhaled Placebo	Inhaled Staccato Placebo, 2 inhalations, 8 hours apart
DRUG	Inhaled Loxapine	Inhaled Staccato Loxapine, 10 mg doses x 2, 8 hours apart

Timeline

• Start date: 2008-11-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2008-11-11
• Last updated: 2019-03-11
• Results posted: 2019-03-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study