Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Alexza Pharmaceuticals, Inc. |
---|---|
Information provided by: | Alexza Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00555412 |
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 |
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
|
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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria include:
Exclusion Criteria include:
United States, Georgia | |
Atlanta Center for Medical Research | |
Atlanta, Georgia, United States, 30308 |
Principal Investigator: | Robert Riesenberg, MD | Atlanta Center for Medical Research |
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 |
Health Authority: | United States: Food and Drug Administration |
pharmacokinetic multidose Staccato Loxapine |
Dopamine Loxapine |
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Physiological Effects of Drugs Psychotropic Drugs |
Central Nervous System Depressants Dopamine Agents Dopamine Antagonists Antipsychotic Agents Central Nervous System Agents Pharmacologic Actions |