Multidose PK Study of Staccato Loxapine
This study has been completed.
Sponsor:
Alexza Pharmaceuticals, Inc.
Information provided by:
Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00555412
First received: November 6, 2007
Last updated: June 2, 2008
Last verified: June 2008
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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 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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:
- 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 |
|---|---|
| Experimental: A |
Drug: loxapine
loxapine aerosol inhalation high dose regimen
Other Name: Staccato Loxapine
|
| Experimental: B |
Drug: loxapine
loxapine aerosol inhalation middle dose regimen
Other Name: Staccato Loxapine
|
| Experimental: C |
Drug: loxapine
loxapine aerosol inhalation low dose regimen
Other Name: Staccato Loxapine
|
| Placebo Comparator: D |
Drug: placebo
placebo aerosol inhalation
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| 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: | Robert Riesenberg, MD, Atlanta Center for Medical Research |
| ClinicalTrials.gov Identifier: | NCT00555412 History of Changes |
| Other Study ID Numbers: | AMDC-004-102 |
| Study First Received: | November 6, 2007 |
| Last Updated: | June 2, 2008 |
| Health Authority: | United States: Food and Drug Administration |
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 Pharmacologic Actions Central Nervous System Agents |
Therapeutic Uses Psychotropic Drugs Dopamine Antagonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 17, 2013