Status:
COMPLETED
Staccato Loxapine PK in Smokers and Nonsmokers
Lead Sponsor:
Alexza Pharmaceuticals, Inc.
Conditions:
Smoking, Cigarette
Eligibility:
All Genders
20-50 years
Phase:
PHASE1
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 inha...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00873769
Start Date
April 1 2009
End Date
June 1 2009
Last Update
March 15 2017
Active Locations (1)
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1
Covance Clinical Research Unit, Inc.
Evansville, Indiana, United States, 47710