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Staccato Loxapine PK in Smokers and Nonsmokers

Sponsor
Alexza Pharmaceuticals, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00873769
Collaborator
(none)
35
Enrollment
1
Location
2
Arms
2
Duration (Months)
17.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Inhaled Loxapine 10 mg
 Phase 1

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 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
35 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Masking Description:
Single-center, single-dose, single-treatment, open label study
Primary Purpose:
Treatment
Official Title:
Pharmacokinetics of Staccato® Loxapine for Inhalation in Smokers Compared to Nonsmokers
Study Start Date :
Apr 1, 2009
Actual Primary Completion Date :
Jun 1, 2009
Actual Study Completion Date :
Jun 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: Healthy smokers

Healthy smokers, male and female

Drug: Inhaled Loxapine 10 mg
Staccato Loxapine 10 mg, single dose
Other Names:
  • Staccato Loxapine 10 mg

    		•
    Experimental: Healthy nonsmokers

    Healthy nonsmokers, Healthy smokers, male and female

    Drug: Inhaled Loxapine 10 mg
    Staccato Loxapine 10 mg, single dose
    Other Names:
  • Staccato Loxapine 10 mg

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Noncompartmental Pharmacokinetic parameters [24 hours]

    Secondary Outcome Measures

    1. Vital signs [24 hours]

    2. Treatment emergent adverse events [24 hours]

    3. Sedation visual analog scale [24 hours]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Covance Clinical Research Unit, Inc. Evansville Indiana United States 47710

    Sponsors and Collaborators

    • Alexza Pharmaceuticals, Inc.

    Investigators

    • Principal Investigator: Randall R. Stoltz, MD, Covance Clincial Research Unit, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Alexza Pharmaceuticals, Inc.
    ClinicalTrials.gov Identifier:
    NCT00873769
    Other Study ID Numbers:
    • AMDC-004-106
    • 27 February 2009
    First Posted:
    Apr 2, 2009
    Last Update Posted:
    Mar 15, 2017
    Last Verified:
    Jun 1, 2009
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Alexza Pharmaceuticals, Inc.
    Staccato Loxapine
    pharmacokinetics
    smokers
    non-smokers
    Additional relevant MeSH terms:
    Loxapine

    Study Results

    No Results Posted as of Mar 15, 2017