Trial | NCT00555412  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    loxapine ...

  • Study Participants

    40
The objectives of this trial are to assess the safety, tolerability, and pharmacokinetics of multiple inhaled doses of Staccato Loxapine.
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 Started
Oct 31
2007
Primary Completion
Dec 31
2007
Study Completion
Dec 31
2007
Last Update
Mar 15
2017

Drug D - inhaled placebo q 4 h x 3

placebo aerosol inhalation (0 mg total)

  • Other names: Staccato Placebo

Drug A - 10 mg loxapine q 4 h x 3 (30 mg total)

loxapine aerosol inhalation high dose regimen (30 mg total)

  • Other names: Staccato Loxapine 10 mg

Drug B - 10 mg x 1, 5 mg x 2 loxapine q 4 h (20 mg total)

loxapine aerosol inhalation middle dose regimen (20 mg total)

  • Other names: Staccato Loxapine 5 and 10 mg

Drug C - 5 mg loxapine q 4 h x 3 (15 mg total)

loxapine aerosol inhalation low dose regimen (15 mg total)

  • Other names: Staccato Loxapine 5 mg

B - 10 mg x 1, 5 mg x 2 loxapine q 4 h (20 mg total) Experimental

A - 10 mg loxapine q 4 h x 3 (30 mg total) Experimental

C - 5 mg loxapine q 4 h x 3 (15 mg total) Experimental

D - inhaled placebo q 4 h x 3 Placebo Comparator

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.
No Results Posted