Pharmacokinetics of Staccato Zaleplon - Full Text View

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Safety, Tolerability, and Pharmacokinetics of a Single Dose of Staccato® Zaleplon for Inhalation in Healthy Volunteers

Resource links provided by NLM:

Drug Information available for: Zaleplon

U.S. FDA Resources

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
Active Comparator: 1 Dose 1	Drug: zaleplon Staccato Zaleplon Other Name: Staccato Zaleplon for Inhalation Drug: placebo Staccato Placebo Other Name: Staccato Placebo for Inhalation
Active Comparator: 2 Dose 2	Drug: zaleplon Staccato Zaleplon Other Name: Staccato Zaleplon for Inhalation Drug: placebo Staccato Placebo Other Name: Staccato Placebo for Inhalation
Active Comparator: 3 Dose 3	Drug: zaleplon Staccato Zaleplon Other Name: Staccato Zaleplon for Inhalation Drug: placebo Staccato Placebo Other Name: Staccato Placebo for Inhalation
Active Comparator: 4 Dose 4	Drug: zaleplon Staccato Zaleplon Other Name: Staccato Zaleplon for Inhalation Drug: placebo Staccato Placebo Other Name: Staccato Placebo for Inhalation

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

No publications provided

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

Keywords provided by Alexza Pharmaceuticals, Inc.:

Healthy adult volunteers

Additional relevant MeSH terms:

Zaleplon
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents

Therapeutic Uses
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anticonvulsants

ClinicalTrials.gov processed this record on February 09, 2012