Staccato Loxapine PK in Smokers and Nonsmokers

Phase 1

Completed

• Conditions: Smoking, Cigarette
• Interventions: Drug: Inhaled Loxapine 10 mg

• Registration Number: NCT00873769
• Lead Sponsor: Alexza Pharmaceuticals, Inc.

Brief 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.

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-01
• Study First Submitted QC: 2009-04-01
• Study First Posted: 2009-04-02
• Status Verified: 2009-06
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Last Update Submitted: 2017-03-13
• Last Update Posted: 2017-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• Normal spirometry at screening and in good general health as determined by a complete medical history, physical examination, 12-lead ECG, blood chemistry profile, hematology, and urinalysis,
• Smokers must have a history of smoking > 15 cigarettes/day currently and for at least the last 2 years,
• Nonsmokers must have never smoked > 5 cigarettes/day and not smoking at all for at least the last 2 years.

Exclusion Criteria

• Any acute illness in the 5 days,
• Use of a bronchodilator for the treatment of wheezing within 12 months, OR
• Any other disease or condition, by history, physical examination, or laboratory abnormalities that would present undue risk to the subject, or may confound the interpretation of study results.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy smokers	Inhaled Loxapine 10 mg	Healthy smokers, male and female
Healthy nonsmokers	Inhaled Loxapine 10 mg	Healthy nonsmokers, Healthy smokers, male and female

Primary Outcome Measures

Name	Time	Method
Noncompartmental Pharmacokinetic parameters	24 hours

Secondary Outcome Measures

Name	Time	Method
Vital signs	24 hours
Treatment emergent adverse events	24 hours
Sedation visual analog scale	24 hours

Trial Locations

Locations (1)

Covance Clinical Research Unit, Inc.; 🇺🇸 Evansville, Indiana, United States