Staccato Zaleplon Single Dose Pharmacokinetics

March 13, 2017 updated by: Alexza Pharmaceuticals, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Covance Clinical Research Unit Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Inhaled Placebo
Staccato Placebo
Drug: Inhaled placebo
Inhaled Staccato Placebo
Other Names:
  • Staccato Placebo
Experimental: Inhaled Zaleplon 0.5 mg
Staccato Zaleplon 0.5 mg
Drug: Inhaled Zaleplon 0.5 mg
Inhaled Staccato Zaleplon 0.5 mg
Other Names:
  • Staccato Zaleplon 0.5 mg
Experimental: Inhaled Zaleplon 1 mg
Staccato Zaleplon 1 mg
Drug: Inhaled Zaleplon 1 mg
Inhaled Staccato Zaleplon 1 mg
Other Names:
  • Staccato Zaleplon 1 mg
Experimental: Inhaled Zaleplon 2 mg
Staccato Zaleplon 2 mg
Drug: Inhaled Zaleplon 2 mg
Inhaled Staccato Zaleplon 2 mg
Other Names:
  • Staccato Zaleplon 2 mg
Experimental: Inhaled Zaleplon 4 mg
Staccato Zaleplon 4 mg
Drug: Inhaled Zaleplon 4 mg
Inhaled Staccato Zaleplon 4 mg
Other Names:
  • Staccato Zaleplon 4 mg

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexza Pharmaceuticals, Inc.

Investigators

  • Study Director: Daniel A Spyker, MD, Alexza Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

February 7, 2008

First Submitted That Met QC Criteria

February 19, 2008

First Posted (Estimate)

February 21, 2008

Study Record Updates

Last Update Posted (Actual)

March 14, 2017

Last Update Submitted That Met QC Criteria

March 13, 2017

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMDC-007-101
  • 17 December 2007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

IPD submitted to regulatory authorities. Others may contact Alexza Pharmaceuticals, Inc. Please send your request to ClinicalTrialsInfo@alexza.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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