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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
  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: 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
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


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 ]

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 ]

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
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
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, see Learn About Clinical Studies.

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

Publications:
Responsible Party: 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: March 13, 2017
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: IPD submitted to regulatory authorities. Others may contact Alexza Pharmaceuticals, Inc. Please send your request to ClinicalTrialsInfo@alexza.com

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:
Zaleplon
Anticonvulsants
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 21, 2017