NCT00555412

Staccato Loxapine Multidose PK

Safety, Tolerability, and Pharmacokinetics of Multiple Doses of Staccato® Loxapine for Inhalation in Subjects on Chronic, Stable Antipsychotic Regimens

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Alexza Pharmaceuticals, Inc. · Unknown
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The objectives of this trial are to assess the safety, tolerability, and pharmacokinetics of multiple inhaled doses of Staccato Loxapine.

Detailed description

The purpose of the present Phase 1 study in schizophrenic patients is to assess the safety and pharmacokinetics of multiple doses of Staccato Loxapine given within a 24 hour time period. The study will be conducted in schizophrenic patients who are on chronic, stable antipsychotic medication. Patients meeting entry criteria will be randomized to one of three dose sequences of Staccato Loxapine or to Staccato Placebo. Following administration of medications, safety, tolerability and pharmacokinetic assessments will be conducted at serial time points.

Conditions

• Volunteers on Chronic, Stable Antipsychotic Regimens

Interventions

Type	Name	Description
DRUG	A - 10 mg loxapine q 4 h x 3 (30 mg total)	loxapine aerosol inhalation high dose regimen (30 mg total)
DRUG	B - 10 mg x 1, 5 mg x 2 loxapine q 4 h (20 mg total)	loxapine aerosol inhalation middle dose regimen (20 mg total)
DRUG	C - 5 mg loxapine q 4 h x 3 (15 mg total)	loxapine aerosol inhalation low dose regimen (15 mg total)
DRUG	D - inhaled placebo q 4 h x 3	placebo aerosol inhalation (0 mg total)

Timeline

• Start date: 2007-10-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2007-11-08
• Last updated: 2017-03-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study