Staccato Zaleplon Single Dose PK

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: July 13, 2013
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: zaleplon
Drug: placebo
Phase 1

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:


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 ]

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: 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 13, 2013
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 April 17, 2014