Staccato Loxapine PK in Smokers and Nonsmokers
Information source: Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Smoking, Cigarette
Intervention: Staccato Loxapine (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Alexza Pharmaceuticals, Inc. Official(s) and/or principal investigator(s): Randall R. Stoltz, MD, Principal Investigator, Affiliation: Covance Clincial Research Unit, Inc.
Summary
The objective of this trial is to assess the pharmacokinetics of a single dose of 10 mg
Staccato Loxapine administered to smokers compared to nonsmokers.
Clinical Details
Official title: Pharmacokinetics of StaccatoŽ Loxapine for Inhalation in Smokers Compared to Nonsmokers
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Noncompartmental Pharmacokinetic parameters
Secondary outcome: Vital signsTreatment emergent adverse events Sedation visual analog scale
Eligibility
Minimum age: 20 Years.
Maximum age: 50 Years.
Gender(s): Both.
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.
Locations and Contacts
Covance Clinical Research Unit, Inc., Evansville, Indiana 47710, United States
Additional Information
Starting date: April 2009
Last updated: June 18, 2009
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