Staccato Loxapine PK in Smokers and Nonsmokers

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Alexza Pharmaceuticals, Inc.
• Treatments: Loxapine

Criteria

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.