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Staccato Zaleplon Single Dose Pharmacokinetics

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00620620
First received: February 7, 2008
Last updated: March 13, 2017
Last verified: July 2013

February 7, 2008
March 13, 2017
February 2008
March 2008   (Final data collection date for primary outcome measure)
Examine the tolerability and safety of Staccato Zaleplon in a healthy volunteer population; [ Time Frame: Single dose ]
Same as current
Complete list of historical versions of study NCT00620620 on ClinicalTrials.gov Archive Site
Establish the plasma level-time profile (pharmacokinetics) of zaleplon in the target therapeutic range following single Staccato Zaleplon doses [ Time Frame: single dose ]
Same as current
Not Provided
Not Provided
 
Staccato Zaleplon Single Dose Pharmacokinetics
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
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Healthy
  • Drug: Inhaled placebo
    Inhaled Staccato Placebo
    Other Name: Staccato Placebo
  • Drug: Inhaled Zaleplon 0.5 mg
    Inhaled Staccato Zaleplon 0.5 mg
    Other Name: Staccato Zaleplon 0.5 mg
  • Drug: Inhaled Zaleplon 1 mg
    Inhaled Staccato Zaleplon 1 mg
    Other Name: Staccato Zaleplon 1 mg
  • Drug: Inhaled Zaleplon 2 mg
    Inhaled Staccato Zaleplon 2 mg
    Other Name: Staccato Zaleplon 2 mg
  • Drug: Inhaled Zaleplon 4 mg
    Inhaled Staccato Zaleplon 4 mg
    Other Name: Staccato Zaleplon 4 mg
  • Placebo Comparator: Inhaled Placebo
    Staccato Placebo
    Intervention: Drug: Inhaled placebo
  • Experimental: Inhaled Zaleplon 0.5 mg
    Staccato Zaleplon 0.5 mg
    Intervention: Drug: Inhaled Zaleplon 0.5 mg
  • Experimental: Inhaled Zaleplon 1 mg
    Staccato Zaleplon 1 mg
    Intervention: Drug: Inhaled Zaleplon 1 mg
  • Experimental: Inhaled Zaleplon 2 mg
    Staccato Zaleplon 2 mg
    Intervention: Drug: Inhaled Zaleplon 2 mg
  • Experimental: Inhaled Zaleplon 4 mg
    Staccato Zaleplon 4 mg
    Intervention: Drug: Inhaled Zaleplon 4 mg
Avram MJ, Spyker DA, Kehne JH, Cassella JV. The pharmacokinetics and pharmacodynamics of zaleplon delivered as a thermally generated aerosol in a single breath to volunteers. J Clin Pharmacol. 2013 Feb;53(2):140-50. doi: 10.1177/0091270012436886.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
March 2008
March 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00620620
AMDC-007-101
17 December 2007
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Yes
IPD submitted to regulatory authorities. Others may contact Alexza Pharmaceuticals, Inc. Please send your request to ClinicalTrialsInfo@alexza.com
Alexza Pharmaceuticals, Inc.
Alexza Pharmaceuticals, Inc.
Not Provided
Study Director: Daniel A Spyker, MD Alexza Pharmaceuticals, Inc.
Alexza Pharmaceuticals, Inc.
July 2013

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