Multidose PK Study of Staccato Loxapine - Full Text View

Sponsor:	Alexza Pharmaceuticals, Inc.
Information provided by:	Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00555412

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: loxapine Drug: placebo	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Pharmacokinetics Study
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:

Drug Information available for: Loxapine succinate Loxapine hydrochloride Loxapine

U.S. FDA Resources

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

Primary Outcome Measures:

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

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
A: Experimental	Drug: loxapine loxapine aerosol inhalation high dose regimen
B: Experimental	Drug: loxapine loxapine aerosol inhalation middle dose regimen
C: Experimental	Drug: loxapine loxapine aerosol inhalation low dose regimen
D: Placebo Comparator	Drug: placebo placebo aerosol inhalation

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

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria include:

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

Subjects who are currently treated with injectable depot neuroleptics within one dose interval must be excluded.
Subjects who have received loxapine or amoxapine within the last 30 days must be excluded.
Subjects with a history of allergy or intolerance to dibenzoxazepines (loxapine and amoxapine) must be excluded.
Subjects with a history of movement disorders including Parkinson's disease or a history of neuroleptic malignant syndrome must be excluded.
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00555412

Locations

United States, Georgia
Atlanta Center for Medical Research
Atlanta, Georgia, United States, 30308

Sponsors and Collaborators

Alexza Pharmaceuticals, Inc.

Investigators

Principal Investigator:

Robert Riesenberg, MD

Atlanta Center for Medical Research

More Information

No publications provided

Responsible Party:	Atlanta Center for Medical Research ( Robert Riesenberg, MD )
Study ID Numbers:	AMDC-004-102
Study First Received:	November 6, 2007
Last Updated:	June 2, 2008
ClinicalTrials.gov Identifier:	NCT00555412 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Alexza Pharmaceuticals, Inc.:

pharmacokinetic
multidose
Staccato Loxapine

Additional relevant MeSH terms:

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

Antipsychotic Agents
Pharmacologic Actions
Therapeutic Uses
Loxapine
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 30, 2009