Staccato Loxapine Pulmonary Safety in Healthy Volunteers

Condition(s) targeted: Healthy

Intervention: Placebo -- Active (Drug); Active -- Placebo (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Alexza Pharmaceuticals, Inc.

Official(s) and/or principal investigator(s):
David S. Miller, MD, Principal Investigator, Affiliation: Northeast Medical Research, North Dartmouth, MA

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

Official title: Pulmonary Safety of Repeat Doses of Staccato® Loxapine for Inhalation in Healthy Volunteers

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change in FEV1 from baseline by spirometry

Secondary outcome:

Change in FVC from baseline by spirometry

Treatment emergent adverse events

Detailed 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.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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

Northeast Medical Research, North Dartmouth, Massachusetts 02747, United States

Starting date: November 2008
Last updated: May 4, 2009