Staccato Loxapine Pulmonary Safety in Healthy Volunteers

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

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

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Inhaled Placebo
* Drug: Inhaled Loxapine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inhaled Placebo crossed over to Inhaled Loxapine<br>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 | Drug: Inhaled Placebo<br>* Inhaled Staccato Placebo, 2 inhalations, 8 hours apart<br>Drug: Inhaled Loxapine<br>* Inhaled Staccato Loxapine, 10 mg doses x 2, 8 hours apart<br>|
| Experimental: Inhaled Loxapine crossed over to Inhaled Placebo<br>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; | Drug: Inhaled Placebo<br>* Inhaled Staccato Placebo, 2 inhalations, 8 hours apart<br>Drug: Inhaled Loxapine<br>* Inhaled Staccato Loxapine, 10 mg doses x 2, 8 hours apart<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Largest Treatment Difference (Loxapine - Placebo) in Change in FEV1 From Baseline by Spirometry | 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, | 17 post-treatment time points (15 min to 32 hr) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Largest Treatment Difference (Loxapine - Placebo) in Change in FVC From Baseline by Spirometry | 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 | 17 post-treatment time points (15 min to 32 hr) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy volunteers