Staccato Loxapine Pulmonary Safety in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Inhaled Placebo; Drug: Inhaled Loxapine

• Registration Number: NCT00789360
• Lead Sponsor: Alexza Pharmaceuticals, Inc.

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-11-07
• Study First Submitted QC: 2008-11-10
• Study First Posted: 2008-11-11
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Status Verified: 2009-05
• Results First Submitted: 2017-03-12
• Results First Submitted QC: 2018-11-18
• Last Update Submitted: 2018-11-18
• Results First Posted: 2019-03-11
• Last Update Posted: 2019-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Inhaled Loxapine crossed over to Inhaled Placebo	Inhaled Loxapine	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;
Inhaled Placebo crossed over to Inhaled Loxapine	Inhaled Loxapine	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
Inhaled Loxapine crossed over to Inhaled Placebo	Inhaled Placebo	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;
Inhaled Placebo crossed over to Inhaled Loxapine	Inhaled Placebo	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

Primary Outcome Measures

Name	Time	Method
The Largest Treatment Difference (Loxapine - Placebo) in Change in FEV1 From Baseline by Spirometry	17 post-treatment time points (15 min to 32 hr)	The largest treatment difference (Loxapine - Placebo) across the 17 post-treatment time points (15 min to 32 hr) in FEV1 Change from Same-Period Baseline,

Secondary Outcome Measures

Name	Time	Method
The Largest Treatment Difference (Loxapine - Placebo) in Change in FVC From Baseline by Spirometry	17 post-treatment time points (15 min to 32 hr)	The largest treatment difference (Loxapine - Placebo) across the 17 post-treatment time points (15 min to 32 hr) in FVC Change from Same-Period Baseline

Trial Locations

Locations (1)

Northeast Medical Research; 🇺🇸 North Dartmouth, Massachusetts, United States