NCT00873769

Staccato Loxapine PK in Smokers and Nonsmokers

Pharmacokinetics of Staccato® Loxapine for Inhalation in Smokers Compared to Nonsmokers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Alexza Pharmaceuticals, Inc. · Unknown
• Sex: All
• Age: 20 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The objective of this trial was to assess the pharmacokinetics of a single dose of 10 mg Staccato Loxapine administered to smokers compared to nonsmokers.

Detailed description

Pharmacokinetics and sedation pharmacodynamics were studied using a visual analog scale were studied in male and female adult subjects (nonsmokers and smokers) following a single dose of 10 mg of inhaled loxapine. Blood samples were drawn at predose, 30 seconds, 1, 2, 3, 10, 30, and 60 minutes, and 2, 6, 12, and 24 hours after dosing. Loxapine and 8-OH-loxapine were analyzed using reverse-phase liquid chromatography coupled with a tandem mass spectrometer.

Conditions

• Smoking, Cigarette

Interventions

Type	Name	Description
DRUG	Inhaled Loxapine 10 mg	Staccato Loxapine 10 mg, single dose

Timeline

• Start date: 2009-04-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2009-04-02
• Last updated: 2017-03-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study