Staccato Zaleplon Single Dose Pharmacokinetics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00620620
Recruitment Status : Completed
First Posted : February 21, 2008
Last Update Posted : March 14, 2017
Information provided by (Responsible Party):
Alexza Pharmaceuticals, Inc.

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

Condition or disease Intervention/treatment Phase
Healthy Drug: Inhaled placebo Drug: Inhaled Zaleplon 0.5 mg Drug: Inhaled Zaleplon 1 mg Drug: Inhaled Zaleplon 2 mg Drug: Inhaled Zaleplon 4 mg Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety, Tolerability, and Pharmacokinetics of a Single Dose of Staccato® Zaleplon for Inhalation in Healthy Volunteers
Study Start Date : February 2008
Primary Completion Date : March 2008
Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Zaleplon
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Inhaled Placebo
Staccato Placebo
Drug: Inhaled placebo
Inhaled Staccato Placebo
Other Name: 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 Name: 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 Name: Staccato Zaleplon 1 mg
Experimental: Inhaled Zaleplon 2 mg
Staccato Zaleplon 2 mg
Drug: Inhaled Zaleplon 2 mg
Inhaled Staccato Zaleplon 2 mg
Other Name: Staccato Zaleplon 2 mg
Experimental: Inhaled Zaleplon 4 mg
Staccato Zaleplon 4 mg
Drug: Inhaled Zaleplon 4 mg
Inhaled Staccato Zaleplon 4 mg
Other Name: Staccato Zaleplon 4 mg

Primary Outcome Measures :
  1. Examine the tolerability and safety of Staccato Zaleplon in a healthy volunteer population; [ Time Frame: Single dose ]

Secondary Outcome Measures :
  1. Establish the plasma level-time profile (pharmacokinetics) of zaleplon in the target therapeutic range following single Staccato Zaleplon doses [ Time Frame: single dose ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00620620

United States, Indiana
Covance Clinical Research Unit Inc.
Evansville, Indiana, United States, 47714
Sponsors and Collaborators
Alexza Pharmaceuticals, Inc.
Study Director: Daniel A Spyker, MD Alexza Pharmaceuticals, Inc.

Responsible Party: Alexza Pharmaceuticals, Inc. Identifier: NCT00620620     History of Changes
Other Study ID Numbers: AMDC-007-101
17 December 2007
First Posted: February 21, 2008    Key Record Dates
Last Update Posted: March 14, 2017
Last Verified: July 2013
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD submitted to regulatory authorities. Others may contact Alexza Pharmaceuticals, Inc. Please send your request to

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Alexza Pharmaceuticals, Inc.:
Healthy adult volunteers

Additional relevant MeSH terms:
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action