Pharmacokinetics of Staccato Zaleplon - Tabular View

Tracking Information

First Received Date ^ICMJE

February 7, 2008

Last Updated Date

July 4, 2008

Start Date ^ICMJE

February 2008

Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Examine the tolerability and safety of Staccato Zaleplon in a healthy volunteer population; [ Time Frame: Single dose ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00620620 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Establish the plasma level-time profile (pharmacokinetics) of zaleplon in the target therapeutic range following single Staccato Zaleplon doses [ Time Frame: single dose ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Pharmacokinetics of Staccato Zaleplon

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Pharmacokinetics Study

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Drug: zaleplon
Drug: placebo

Study Arms / Comparison Groups

Active Comparator: Dose 1
Active Comparator: Dose 2
Active Comparator: Dose 3
Active Comparator: Dose 4

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

March 2008

Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00620620

Responsible Party

Robert S. Fishman, MD, FCCP; Vice President, Medical Affairs, Alexza Pharmaceuticals, Inc

Study ID Numbers ^ICMJE

AMDC-007-101, 17 December 2007

Study Sponsor ^ICMJE

Alexza Pharmaceuticals, Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Daniel A Spyker, MD

Alexza Pharmaceuticals, Inc.

Information Provided By

Alexza Pharmaceuticals, Inc.

Verification Date

July 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP