Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT00620620
Status:
COMPLETED
Last Update Posted:
2017-03-14
First Post:
2008-02-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Staccato Zaleplon Single Dose Pharmacokinetics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-13', 'studyFirstSubmitDate': '2008-02-07', 'studyFirstSubmitQcDate': '2008-02-19', 'lastUpdatePostDateStruct': {'date': '2017-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-02-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Examine the tolerability and safety of Staccato Zaleplon in a healthy volunteer population;', 'timeFrame': 'Single dose'}], 'secondaryOutcomes': [{'measure': 'Establish the plasma level-time profile (pharmacokinetics) of zaleplon in the target therapeutic range following single Staccato Zaleplon doses', 'timeFrame': 'single dose'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Healthy adult volunteers'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '23436259', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male and female subjects between the ages of 18 to 55 years, inclusive who are in good general health\n\nExclusion Criteria:\n\n* 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."}, 'identificationModule': {'nctId': 'NCT00620620', 'briefTitle': 'Staccato Zaleplon Single Dose Pharmacokinetics', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alexza Pharmaceuticals, Inc.'}, 'officialTitle': 'Safety, Tolerability, and Pharmacokinetics of a Single Dose of Staccato® Zaleplon for Inhalation in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'AMDC-007-101'}, 'secondaryIdInfos': [{'id': '17 December 2007'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Inhaled Placebo', 'description': 'Staccato Placebo', 'interventionNames': ['Drug: Inhaled placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Inhaled Zaleplon 0.5 mg', 'description': 'Staccato Zaleplon 0.5 mg', 'interventionNames': ['Drug: Inhaled Zaleplon 0.5 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Inhaled Zaleplon 1 mg', 'description': 'Staccato Zaleplon 1 mg', 'interventionNames': ['Drug: Inhaled Zaleplon 1 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Inhaled Zaleplon 2 mg', 'description': 'Staccato Zaleplon 2 mg', 'interventionNames': ['Drug: Inhaled Zaleplon 2 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Inhaled Zaleplon 4 mg', 'description': 'Staccato Zaleplon 4 mg', 'interventionNames': ['Drug: Inhaled Zaleplon 4 mg']}], 'interventions': [{'name': 'Inhaled placebo', 'type': 'DRUG', 'otherNames': ['Staccato Placebo'], 'description': 'Inhaled Staccato Placebo', 'armGroupLabels': ['Inhaled Placebo']}, {'name': 'Inhaled Zaleplon 0.5 mg', 'type': 'DRUG', 'otherNames': ['Staccato Zaleplon 0.5 mg'], 'description': 'Inhaled Staccato Zaleplon 0.5 mg', 'armGroupLabels': ['Inhaled Zaleplon 0.5 mg']}, {'name': 'Inhaled Zaleplon 1 mg', 'type': 'DRUG', 'otherNames': ['Staccato Zaleplon 1 mg'], 'description': 'Inhaled Staccato Zaleplon 1 mg', 'armGroupLabels': ['Inhaled Zaleplon 1 mg']}, {'name': 'Inhaled Zaleplon 2 mg', 'type': 'DRUG', 'otherNames': ['Staccato Zaleplon 2 mg'], 'description': 'Inhaled Staccato Zaleplon 2 mg', 'armGroupLabels': ['Inhaled Zaleplon 2 mg']}, {'name': 'Inhaled Zaleplon 4 mg', 'type': 'DRUG', 'otherNames': ['Staccato Zaleplon 4 mg'], 'description': 'Inhaled Staccato Zaleplon 4 mg', 'armGroupLabels': ['Inhaled Zaleplon 4 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '47714', 'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'facility': 'Covance Clinical Research Unit Inc.', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}], 'overallOfficials': [{'name': 'Daniel A Spyker, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alexza Pharmaceuticals, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'IPD submitted to regulatory authorities. Others may contact Alexza Pharmaceuticals, Inc. Please send your request to ClinicalTrialsInfo@alexza.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexza Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}