Staccato Loxapine PK in Smokers and Nonsmokers

Completed · Phase 1

Conditions studied: Smoking, Cigarette

In brief

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.

Key facts

Study ID

NCT00873769

Run by

Alexza Pharmaceuticals, Inc.

People needed

35

Starts

2009-04-01

Expected to finish

2009-06-01

Last updated by the study team

2017-03-15

Who can join

Age: 20 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Covance Clinical Research Unit, Inc. — Evansville, Indiana, United States

Full record on ClinicalTrials.gov

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