Staccato Loxapine Multidose PK
Information source: Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Volunteers on Chronic, Stable Antipsychotic Regimens
Intervention: A - 10 mg loxapine q 4 h x 3 (30 mg total) (Drug); B - 10 mg x 1, 5 mg x 2 loxapine q 4 h (20 mg total) (Drug); C - 5 mg loxapine q 4 h x 3 (15 mg total) (Drug); D - inhaled placebo q 4 h x 3 (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Alexza Pharmaceuticals, Inc. Official(s) and/or principal investigator(s): Robert Riesenberg, MD, Principal Investigator, Affiliation: Atlanta Center for Medical Research
Summary
The objectives of this trial are to assess the safety, tolerability, and pharmacokinetics of
multiple inhaled doses of Staccato Loxapine.
Clinical Details
Official title: Safety, Tolerability, and Pharmacokinetics of Multiple Doses of StaccatoŽ Loxapine for Inhalation in Subjects on Chronic, Stable Antipsychotic Regimens
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: PK parameters: tmax, Cmax, AUClast, AUCinf, ke, t1/2 and clearance will be estimated for each subject and for the population using noncompartmental methods.
Secondary outcome: Plasma concentration-time (PK) profiles will be produced for each subject and a mean PK profile for subjects completing for each dose groupTolerability will be assessed based on treatment emergent adverse events, vital signs, ECG and a visual-analog sedation scale.
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
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
Atlanta Center for Medical Research, Atlanta, Georgia 30308, United States
Additional Information
Starting date: October 2007
Last updated: June 24, 2013
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