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Staccato Loxapine Multidose PK

Sponsor
Alexza Pharmaceuticals, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00555412
Collaborator
Atlanta Center for Medical Research (Other)
40
Enrollment
1
Location
4
Arms
2
Duration (Months)
20
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objectives of this trial are to assess the safety, tolerability, and pharmacokinetics of multiple inhaled doses of Staccato Loxapine.

Condition or Disease Intervention/Treatment Phase
  • Drug: A - 10 mg loxapine q 4 h x 3 (30 mg total)
  • Drug: B - 10 mg x 1, 5 mg x 2 loxapine q 4 h (20 mg total)
  • Drug: C - 5 mg loxapine q 4 h x 3 (15 mg total)
  • Drug: D - inhaled placebo q 4 h x 3
 Phase 1

Detailed Description

The purpose of the present Phase 1 study in schizophrenic patients is to assess the safety and pharmacokinetics of multiple doses of Staccato Loxapine given within a 24 hour time period. The study will be conducted in schizophrenic patients who are on chronic, stable antipsychotic medication. Patients meeting entry criteria will be randomized to one of three dose sequences of Staccato Loxapine or to Staccato Placebo. Following administration of medications, safety, tolerability and pharmacokinetic assessments will be conducted at serial time points.

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Safety, Tolerability, and Pharmacokinetics of Multiple Doses of Staccato® Loxapine for Inhalation in Subjects on Chronic, Stable Antipsychotic Regimens
Study Start Date :
Oct 1, 2007
Actual Primary Completion Date :
Dec 1, 2007
Actual Study Completion Date :
Dec 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: A - 10 mg loxapine q 4 h x 3 (30 mg total)

Drug: A - 10 mg loxapine q 4 h x 3 (30 mg total)
loxapine aerosol inhalation high dose regimen (30 mg total)
Other Names:
  • Staccato Loxapine 10 mg

    		•
    Experimental: B - 10 mg x 1, 5 mg x 2 loxapine q 4 h (20 mg total)

    Drug: B - 10 mg x 1, 5 mg x 2 loxapine q 4 h (20 mg total)
    loxapine aerosol inhalation middle dose regimen (20 mg total)
    Other Names:
  • Staccato Loxapine 5 and 10 mg

    		•
    Experimental: C - 5 mg loxapine q 4 h x 3 (15 mg total)

    Drug: C - 5 mg loxapine q 4 h x 3 (15 mg total)
    loxapine aerosol inhalation low dose regimen (15 mg total)
    Other Names:
  • Staccato Loxapine 5 mg

    		•
    Placebo Comparator: D - inhaled placebo q 4 h x 3

    Drug: D - inhaled placebo q 4 h x 3
    placebo aerosol inhalation (0 mg total)
    Other Names:
  • Staccato Placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. PK parameters: tmax, Cmax, AUClast, AUCinf, ke, t1/2 and clearance will be estimated for each subject and for the population using noncompartmental methods. [48 hours]

    Secondary Outcome Measures

    1. Plasma concentration-time (PK) profiles will be produced for each subject and a mean PK profile for subjects completing for each dose group [24 hours]

    2. Tolerability will be assessed based on treatment emergent adverse events, vital signs, ECG and a visual-analog sedation scale. [24 hours]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria include:

    1. Male and female subjects between the ages of 18 to 65 years, inclusive.

    2. Subjects who are on stable, oral, chronic (>2 mos) antipsychotic medication regimen and who are able to tolerate the rapid oral dose taper and substitution regimen.

    Exclusion Criteria include:

    1. Subjects who are currently treated with injectable depot neuroleptics within one dose interval must be excluded.

    2. Subjects who have received loxapine or amoxapine within the last 30 days must be excluded.

    3. Subjects with a history of allergy or intolerance to dibenzoxazepines (loxapine and amoxapine) must be excluded.

    4. Subjects with a history of movement disorders including Parkinson's disease or a history of neuroleptic malignant syndrome must be excluded.

    5. Subjects who have a history within the past year of drug or alcohol dependence or abuse as defined by DSM-4 must be excluded.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Atlanta Center for Medical Research Atlanta Georgia United States 30308

    Sponsors and Collaborators

    • Alexza Pharmaceuticals, Inc.
    • Atlanta Center for Medical Research

    Investigators

    • Principal Investigator: Robert Riesenberg, MD, Atlanta Center for Medical Research

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Alexza Pharmaceuticals, Inc.
    ClinicalTrials.gov Identifier:
    NCT00555412
    Other Study ID Numbers:
    • AMDC-004-102
    First Posted:
    Nov 8, 2007
    Last Update Posted:
    Mar 15, 2017
    Last Verified:
    Jun 1, 2013
    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.
    pharmacokinetic
    multidose
    Staccato Loxapine
    Additional relevant MeSH terms:
    Loxapine

    Study Results

    No Results Posted as of Mar 15, 2017