Pharmacokinetics of Staccato Zaleplon - Full Text View

Sponsored by:	Alexza Pharmaceuticals, Inc.
Information provided by:	Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00620620

Purpose

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

Condition	Intervention	Phase
Healthy	Drug: zaleplon Drug: placebo	Phase I

Drug Information available for: Zaleplon

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Pharmacokinetics Study
Official Title:	Safety, Tolerability, and Pharmacokinetics of a Single Dose of Staccato® Zaleplon for Inhalation in Healthy Volunteers

Further study details as provided by Alexza Pharmaceuticals, Inc.:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	40
Study Start Date:	February 2008
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Dose 1	Drug: zaleplon Staccato Zaleplon Drug: placebo Staccato Placebo
2: Active Comparator Dose 2	Drug: zaleplon Staccato Zaleplon Drug: placebo Staccato Placebo
3: Active Comparator Dose 3	Drug: zaleplon Staccato Zaleplon Drug: placebo Staccato Placebo
4: Active Comparator Dose 4	Drug: zaleplon Staccato Zaleplon Drug: placebo Staccato Placebo

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00620620

Locations

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

Sponsors and Collaborators

Alexza Pharmaceuticals, Inc.

Investigators

Study Director:

Daniel A Spyker, MD

Alexza Pharmaceuticals, Inc.

More Information

Responsible Party:	Alexza Pharmaceuticals, Inc ( Robert S. Fishman, MD, FCCP; Vice President, Medical Affairs )
Study ID Numbers:	AMDC-007-101, 17 December 2007
Study First Received:	February 7, 2008
Last Updated:	July 4, 2008
ClinicalTrials.gov Identifier:	NCT00620620
Health Authority:	United States: Food and Drug Administration

Keywords provided by Alexza Pharmaceuticals, Inc.:

Healthy adult volunteers

Study placed in the following topic categories:

Zaleplon
Healthy

Additional relevant MeSH terms:

Therapeutic Uses
Physiological Effects of Drugs
Hypnotics and Sedatives
Central Nervous System Depressants

Central Nervous System Agents
Anticonvulsants
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009