Pharmacokinetics of Staccato Zaleplon
This study has been completed.
Sponsor:
Alexza Pharmaceuticals, Inc.
Information provided by:
Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00620620
First received: February 7, 2008
Last updated: July 4, 2008
Last verified: July 2008
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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 ]
| 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 May 19, 2013