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Staccato Loxapine Multidose PK

Sponsored by Alexza Pharmaceuticals, Inc.

About this trial

Last updated 9 years ago

Study ID

AMDC-004-102

Status

Completed

Type

Interventional

Phase

Phase 1

Placebo

No

Accepting

18 to 65 Years
All Sexes

Trial Timing

Ended 18 years ago

What is this trial about?

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

What are the Participation Requirements?

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.