Staccato Loxapine Pulmonary Safety in Healthy Volunteers

Alexza Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Inhaled Placebo; Drug: Inhaled Loxapine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00789360

AMDC-004-104

12 September 2008

Details and patient eligibility

About

The objective of this trial is to assess the pulmonary safety of 2 inhaled doses of Staccato Loxapine within a day.

Full description

The planned study is a multiple dose, double-blind, placebo-controlled, randomized, 2-sequence, 2-period crossover study investigating pulmonary safety in healthy volunteers.

Enrollment: 30 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• nonsmoker subjects in good general health with normal spirometry at screening AND baseline

Exclusion criteria

• history of asthma, COPD, or any other acute or chronic pulmonary disease or bronchodilator use

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups

Inhaled Placebo crossed over to Inhaled Loxapine

Experimental group

Description:

Inhaled Staccato Placebo, 2 inhalations, 8 hours apart; washout of at least 4 days; Inhaled Staccato Loxapine, 10 mg oses x 2, 8 hours apart

Treatment:

Drug: Inhaled Placebo

Drug: Inhaled Loxapine

Inhaled Loxapine crossed over to Inhaled Placebo

Experimental group

Description:

Inhaled Staccato Loxapine, 10 mg doses x 2, 8 hours apart; washout of at least 4 days; Inhaled Staccato Placebo, 2 inhalations, 8 hours apart;

Treatment:

Drug: Inhaled Placebo

Drug: Inhaled Loxapine