Staccato Loxapine PK in Smokers and Nonsmokers

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pharmacokinetics of Staccato® Loxapine for Inhalation in Smokers Compared to Nonsmokers

Conditions
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Smoking, Cigarette

Intervention / Treatment
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* Drug: Inhaled Loxapine 10 mg


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy smokers<br>Healthy smokers, male and female | Drug: Inhaled Loxapine 10 mg<br>* Staccato Loxapine 10 mg, single dose<br>* Other names: Staccato Loxapine 10 mg;|
| Experimental: Healthy nonsmokers<br>Healthy nonsmokers, Healthy smokers, male and female | Drug: Inhaled Loxapine 10 mg<br>* Staccato Loxapine 10 mg, single dose<br>* Other names: Staccato Loxapine 10 mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Noncompartmental Pharmacokinetic parameters |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vital signs |  | 24 hours | 
| Treatment emergent adverse events |  | 24 hours | 
| Sedation visual analog scale |  | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Staccato Loxapine, pharmacokinetics, smokers, non-smokers