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

Condition Intervention Phase
Volunteers on Chronic, Stable Antipsychotic Regimens 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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Alexza Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 40
Study Start Date: October 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: Staccato Placebo

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00555412


Locations
United States, Georgia
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
  More Information

Publications:
Responsible Party: Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00555412     History of Changes
Other Study ID Numbers: AMDC-004-102
First Submitted: November 6, 2007
First Posted: November 8, 2007
Last Update Posted: March 15, 2017
Last Verified: June 2013
Individual Participant Data (IPD) Sharing Statement:
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

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
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action