Staccato Zaleplon Single Dose Pharmacokinetics

Study Overview
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Brief Summary
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The purpose of the study is to determine the safety, tolerability and pharmacokinetics of zaleplon delivered by the Staccato thermal aerosol system in healthy volunteers

Official Title
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Safety, Tolerability, and Pharmacokinetics of a Single Dose of Staccato® Zaleplon for Inhalation in Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: Inhaled placebo
* Drug: Inhaled Zaleplon 0.5 mg
* Drug: Inhaled Zaleplon 1 mg
* Drug: Inhaled Zaleplon 2 mg
* Drug: Inhaled Zaleplon 4 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female subjects between the ages of 18 to 55 years, inclusive who are in good general health Exclusion Criteria: Subjects with a history of allergy or intolerance to zaleplon. Subjects who have any other disease or condition, by history, physical examination, or laboratory abnormalities that in the investigator's opinion, would present undue risk to the subject, or may confound the interpretation of study results.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Inhaled Placebo<br>Staccato Placebo | Drug: Inhaled placebo<br>* Inhaled Staccato Placebo<br>* Other names: Staccato Placebo;|
| Experimental: Inhaled Zaleplon 0.5 mg<br>Staccato Zaleplon 0.5 mg | Drug: Inhaled Zaleplon 0.5 mg<br>* Inhaled Staccato Zaleplon 0.5 mg<br>* Other names: Staccato Zaleplon 0.5 mg;|
| Experimental: Inhaled Zaleplon 1 mg<br>Staccato Zaleplon 1 mg | Drug: Inhaled Zaleplon 1 mg<br>* Inhaled Staccato Zaleplon 1 mg<br>* Other names: Staccato Zaleplon 1 mg;|
| Experimental: Inhaled Zaleplon 2 mg<br>Staccato Zaleplon 2 mg | Drug: Inhaled Zaleplon 2 mg<br>* Inhaled Staccato Zaleplon 2 mg<br>* Other names: Staccato Zaleplon 2 mg;|
| Experimental: Inhaled Zaleplon 4 mg<br>Staccato Zaleplon 4 mg | Drug: Inhaled Zaleplon 4 mg<br>* Inhaled Staccato Zaleplon 4 mg<br>* Other names: Staccato Zaleplon 4 mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Examine the tolerability and safety of Staccato Zaleplon in a healthy volunteer population; |  | Single dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Establish the plasma level-time profile (pharmacokinetics) of zaleplon in the target therapeutic range following single Staccato Zaleplon doses |  | single dose | 

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