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Completed

NCT Number: NCT00620620

Staccato Zaleplon Single Dose Pharmacokinetics

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

Completed

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Unit Inc.

Evansville, Indiana, 47714, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Inhaled placebo

Drug

Inhaled Staccato Placebo

Other names: Staccato Placebo

Inhaled Zaleplon 0.5 mg

Drug

Inhaled Staccato Zaleplon 0.5 mg

Other names: Staccato Zaleplon 0.5 mg

Inhaled Zaleplon 1 mg

Drug

Inhaled Staccato Zaleplon 1 mg

Other names: Staccato Zaleplon 1 mg

Inhaled Zaleplon 2 mg

Drug

Inhaled Staccato Zaleplon 2 mg

Other names: Staccato Zaleplon 2 mg

Inhaled Zaleplon 4 mg

Drug

Inhaled Staccato Zaleplon 4 mg

Other names: Staccato Zaleplon 4 mg

Primary outcomes

  1. Examine the tolerability and safety of Staccato Zaleplon in a healthy volunteer population;

    Time frame: Single dose

Secondary outcomes

  1. Establish the plasma level-time profile (pharmacokinetics) of zaleplon in the target therapeutic range following single Staccato Zaleplon doses

    Time frame: single dose

Sponsors and collaborators

Lead sponsor

Alexza Pharmaceuticals, Inc.

Unknown

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Feb 21, 2008
Registry last updated
Mar 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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