Multidose PK Study of Staccato Loxapine - Tabular View

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Multidose PK Study of Staccato Loxapine

This study has been completed.

Study NCT00555412. Last updated on June 2, 2008. Information provided by Alexza Pharmaceuticals, Inc.

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Multidose PK Study of Staccato Loxapine

Official Title ^†

Safety, Tolerability, and Pharmacokinetics of Multiple Doses of Staccato® Loxapine for Inhalation in Subjects on Chronic, Stable Antipsychotic Regimens

Brief Summary

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

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 Phase

Phase I

Study Type ^†

Interventional

Study Design ^†

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

Primary Outcome Measure ^†

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 Measure ^†

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 ]

Condition ^†

Volunteers on Chronic, Stable Antipsychotic Regimens

Intervention ^†

Drug: loxapine
Drug: placebo

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

Start Date ^†

October 2007

Completion Date

December 2007

Eligibility 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.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00555412

Organization ID

AMDC-004-102

Secondary IDs ^††

Study Sponsor ^†

Alexza Pharmaceuticals, Inc.

Collaborators ^††

Investigators ^†

Principal Investigator:

Robert Riesenberg, MD

Atlanta Center for Medical Research

Information Provided By

Alexza Pharmaceuticals, Inc.

Verification Date

June 2008

First Received Date ^†

November 6, 2007

Last Updated Date

June 2, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.