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Staccato Loxapine Multidose PK

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00555412
First Posted: November 8, 2007
Last Update Posted: March 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Atlanta Center for Medical Research
Information provided by (Responsible Party):
Alexza Pharmaceuticals, Inc.
November 6, 2007
November 8, 2007
March 15, 2017
October 2007
December 2007   (Final data collection date for primary outcome measure)
PK parameters: tmax, Cmax, AUClast, AUCinf, ke, t1/2 and clearance will be estimated for each subject and for the population using noncompartmental methods. [ Time Frame: 48 hours ]
Tolerability will be assessed based on treatment emergent adverse events, vital signs, ECG and a visual-analog sedation scale. [ Time Frame: 48 hours ]
Complete list of historical versions of study NCT00555412 on ClinicalTrials.gov Archive Site
  • Plasma concentration-time (PK) profiles will be produced for each subject and a mean PK profile for subjects completing for each dose group [ Time Frame: 24 hours ]
  • Tolerability will be assessed based on treatment emergent adverse events, vital signs, ECG and a visual-analog sedation scale. [ Time Frame: 24 hours ]
  • Plasma concentration-time (PK) profiles will be produced for each subject and a mean PK profile for subjects completing for each dose group [ Time Frame: 24 hours ]
  • PK parameters: tmax, Cmax, AUClast, AUCinf, ke, t1/2 and clearance will be estimated for each subject and for the population using noncompartmental methods. [ Time Frame: 24 hours ]
Not Provided
Not Provided
 
Staccato Loxapine Multidose PK
Safety, Tolerability, and Pharmacokinetics of Multiple Doses of Staccato® Loxapine for Inhalation in Subjects on Chronic, Stable Antipsychotic Regimens
The objectives of this trial are to assess the safety, tolerability, and pharmacokinetics of multiple inhaled doses of Staccato Loxapine.
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.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Volunteers on Chronic, Stable Antipsychotic Regimens
  • Drug: A - 10 mg loxapine q 4 h x 3 (30 mg total)
    loxapine aerosol inhalation high dose regimen (30 mg total)
    Other Name: Staccato Loxapine 10 mg
  • 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 Name: Staccato Loxapine 5 and 10 mg
  • Drug: C - 5 mg loxapine q 4 h x 3 (15 mg total)
    loxapine aerosol inhalation low dose regimen (15 mg total)
    Other Name: Staccato Loxapine 5 mg
  • Drug: D - inhaled placebo q 4 h x 3
    placebo aerosol inhalation (0 mg total)
    Other Name: Staccato Placebo
  • Experimental: A - 10 mg loxapine q 4 h x 3 (30 mg total)
    Intervention: Drug: A - 10 mg loxapine q 4 h x 3 (30 mg total)
  • Experimental: B - 10 mg x 1, 5 mg x 2 loxapine q 4 h (20 mg total)
    Intervention: Drug: B - 10 mg x 1, 5 mg x 2 loxapine q 4 h (20 mg total)
  • Experimental: C - 5 mg loxapine q 4 h x 3 (15 mg total)
    Intervention: Drug: C - 5 mg loxapine q 4 h x 3 (15 mg total)
  • Placebo Comparator: D - inhaled placebo q 4 h x 3
    Intervention: Drug: D - inhaled placebo q 4 h x 3
Spyker DA, Riesenberg RA, Cassella JV. Multiple dose pharmacokinetics of inhaled loxapine in subjects on chronic, stable antipsychotic regimens. J Clin Pharmacol. 2015 Sep;55(9):985-94. doi: 10.1002/jcph.502. Epub 2015 May 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
December 2007
December 2007   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00555412
AMDC-004-102
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Yes
Plan Description: IPD submitted to regulatory authorities. Others may contact Alexza Pharmaceuticals, Inc. Please send your request to ClinicalTrialsInfo@alexza.com
Alexza Pharmaceuticals, Inc.
Alexza Pharmaceuticals, Inc.
Atlanta Center for Medical Research
Principal Investigator: Robert Riesenberg, MD Atlanta Center for Medical Research
Alexza Pharmaceuticals, Inc.
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP