Expired Study
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Atlanta, Georgia 30308


Purpose:

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


Study summary:

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.


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.


Study is Available At:


Original ID:

AMDC-004-102


NCT ID:

NCT00555412


Secondary ID:


Study Acronym:


Brief Title:

Staccato Loxapine Multidose PK


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Alexza Pharmaceuticals, Inc.


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

4


Number of Groups:

0


Total Enrollment:

40


Enrollment Type:

Actual


Overall Contact Information

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

Study Dates

Start Date:October 2007
Completion Date:December 2007
Completion Type:Actual
Primary Completion Date:December 2007
Primary Completion Type:Actual
Verification Date:June 2013
Last Changed Date:March 13, 2017
First Received Date:November 6, 2007

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Tolerability will be assessed based on treatment emergent adverse events, vital signs, ECG and a visual-analog sedation scale.
Time Frame:24 hours
Safety Issues:False
Outcome Type: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
Safety Issues:False
Outcome Type: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
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:A - 10 mg loxapine q 4 h x 3 (30 mg total)
Description:loxapine aerosol inhalation high dose regimen (30 mg total)
Arm Name:A - 10 mg loxapine q 4 h x 3 (30 mg total)
Other Name:Staccato Loxapine 10 mg
Intervention Type:Drug
Name:B - 10 mg x 1, 5 mg x 2 loxapine q 4 h (20 mg tota
Description:loxapine aerosol inhalation middle dose regimen (20 mg total)
Arm Name:B - 10 mg x 1, 5 mg x 2 loxapine q 4 h (20 mg tota
Other Name:Staccato Loxapine 5 and 10 mg
Intervention Type:Drug
Name:C - 5 mg loxapine q 4 h x 3 (15 mg total)
Description:loxapine aerosol inhalation low dose regimen (15 mg total)
Arm Name:C - 5 mg loxapine q 4 h x 3 (15 mg total)
Other Name:Staccato Loxapine 5 mg
Intervention Type:Drug
Name:D - inhaled placebo q 4 h x 3
Description:placebo aerosol inhalation (0 mg total)
Arm Name:D - inhaled placebo q 4 h x 3
Other Name:Staccato Placebo

Study Arms

Study Arm Type:Experimental
Arm Name:A - 10 mg loxapine q 4 h x 3 (30 mg total)
Study Arm Type:Experimental
Arm Name:B - 10 mg x 1, 5 mg x 2 loxapine q 4 h (20 mg total)
Study Arm Type:Placebo Comparator
Arm Name:D - inhaled placebo q 4 h x 3
Study Arm Type:Experimental
Arm Name:C - 5 mg loxapine q 4 h x 3 (15 mg total)

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Alexza Pharmaceuticals, Inc.
Agency Class:Other
Agency Type:Collaborator
Agency Name:Atlanta Center for Medical Research

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation: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.
PMID:25808074

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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