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Staccato Zaleplon Single Dose Pharmacokinetics

NCT ID: NCT00620620

Last Updated: 2017-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2008-03-31

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

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Inhaled Placebo

Staccato Placebo

Group Type PLACEBO_COMPARATOR

Inhaled placebo

Intervention Type DRUG

Inhaled Staccato Placebo

Inhaled Zaleplon 0.5 mg

Staccato Zaleplon 0.5 mg

Group Type EXPERIMENTAL

Inhaled Zaleplon 0.5 mg

Intervention Type DRUG

Inhaled Staccato Zaleplon 0.5 mg

Inhaled Zaleplon 1 mg

Staccato Zaleplon 1 mg

Group Type EXPERIMENTAL

Inhaled Zaleplon 1 mg

Intervention Type DRUG

Inhaled Staccato Zaleplon 1 mg

Inhaled Zaleplon 2 mg

Staccato Zaleplon 2 mg

Group Type EXPERIMENTAL

Inhaled Zaleplon 2 mg

Intervention Type DRUG

Inhaled Staccato Zaleplon 2 mg

Inhaled Zaleplon 4 mg

Staccato Zaleplon 4 mg

Group Type EXPERIMENTAL

Inhaled Zaleplon 4 mg

Intervention Type DRUG

Inhaled Staccato Zaleplon 4 mg

Interventions

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Inhaled placebo

Inhaled Staccato Placebo

Intervention Type DRUG

Inhaled Zaleplon 0.5 mg

Inhaled Staccato Zaleplon 0.5 mg

Intervention Type DRUG

Inhaled Zaleplon 1 mg

Inhaled Staccato Zaleplon 1 mg

Intervention Type DRUG

Inhaled Zaleplon 2 mg

Inhaled Staccato Zaleplon 2 mg

Intervention Type DRUG

Inhaled Zaleplon 4 mg

Inhaled Staccato Zaleplon 4 mg

Intervention Type DRUG

Other Intervention Names

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Staccato Placebo Staccato Zaleplon 0.5 mg Staccato Zaleplon 1 mg Staccato Zaleplon 2 mg Staccato Zaleplon 4 mg

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Alexza Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel A Spyker, MD

Role: STUDY_DIRECTOR

Alexza Pharmaceuticals, Inc.

Locations

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Covance Clinical Research Unit Inc.

Evansville, Indiana, United States

Site Status

Countries

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United States

References

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Avram MJ, Spyker DA, Kehne JH, Cassella JV. The pharmacokinetics and pharmacodynamics of zaleplon delivered as a thermally generated aerosol in a single breath to volunteers. J Clin Pharmacol. 2013 Feb;53(2):140-50. doi: 10.1177/0091270012436886.

Reference Type BACKGROUND
PMID: 23436259 (View on PubMed)

Other Identifiers

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17 December 2007

Identifier Type: -

Identifier Source: secondary_id

AMDC-007-101

Identifier Type: -

Identifier Source: org_study_id

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