Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2026-01-01 @ 11:34 PM
Study NCT ID:
NCT00873769
Status:
COMPLETED
Last Update Posted:
2017-03-15
First Post:
2009-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Staccato Loxapine PK in Smokers and Nonsmokers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073865', 'term': 'Cigarette Smoking'}], 'ancestors': [{'id': 'D000073869', 'term': 'Tobacco Smoking'}, {'id': 'D012907', 'term': 'Smoking'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D064424', 'term': 'Tobacco Use'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Single-center, single-dose, single-treatment, open label study'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-13', 'studyFirstSubmitDate': '2009-04-01', 'studyFirstSubmitQcDate': '2009-04-01', 'lastUpdatePostDateStruct': {'date': '2017-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-04-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Noncompartmental Pharmacokinetic parameters', 'timeFrame': '24 hours'}], 'secondaryOutcomes': [{'measure': 'Vital signs', 'timeFrame': '24 hours'}, {'measure': 'Treatment emergent adverse events', 'timeFrame': '24 hours'}, {'measure': 'Sedation visual analog scale', 'timeFrame': '24 hours'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Staccato Loxapine', 'pharmacokinetics', 'smokers', 'non-smokers'], 'conditions': ['Smoking, Cigarette']}, 'referencesModule': {'references': [{'pmid': '24937085', 'type': 'BACKGROUND', 'citation': 'Takahashi LH, Huie K, Spyker DA, Fishman RS, Cassella JV. Effect of smoking on the pharmacokinetics of inhaled loxapine. Ther Drug Monit. 2014 Oct;36(5):618-23. doi: 10.1097/FTD.0000000000000048.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this trial was to assess the pharmacokinetics of a single dose of 10 mg Staccato Loxapine administered to smokers compared to nonsmokers.', 'detailedDescription': 'Pharmacokinetics and sedation pharmacodynamics were studied using a visual analog scale were studied in male and female adult subjects (nonsmokers and smokers) following a single dose of 10 mg of inhaled loxapine. Blood samples were drawn at predose, 30 seconds, 1, 2, 3, 10, 30, and 60 minutes, and 2, 6, 12, and 24 hours after dosing. Loxapine and 8-OH-loxapine were analyzed using reverse-phase liquid chromatography coupled with a tandem mass spectrometer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Normal spirometry at screening and in good general health as determined by a complete medical history, physical examination, 12-lead ECG, blood chemistry profile, hematology, and urinalysis,\n* Smokers must have a history of smoking \\> 15 cigarettes/day currently and for at least the last 2 years,\n* Nonsmokers must have never smoked \\> 5 cigarettes/day and not smoking at all for at least the last 2 years.\n\nExclusion Criteria:\n\n* Any acute illness in the 5 days,\n* Use of a bronchodilator for the treatment of wheezing within 12 months, OR\n* Any other disease or condition, by history, physical examination, or laboratory abnormalities that would present undue risk to the subject, or may confound the interpretation of study results.'}, 'identificationModule': {'nctId': 'NCT00873769', 'briefTitle': 'Staccato Loxapine PK in Smokers and Nonsmokers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alexza Pharmaceuticals, Inc.'}, 'officialTitle': 'Pharmacokinetics of Staccato® Loxapine for Inhalation in Smokers Compared to Nonsmokers', 'orgStudyIdInfo': {'id': 'AMDC-004-106'}, 'secondaryIdInfos': [{'id': '27 February 2009'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy smokers', 'description': 'Healthy smokers, male and female', 'interventionNames': ['Drug: Inhaled Loxapine 10 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Healthy nonsmokers', 'description': 'Healthy nonsmokers, Healthy smokers, male and female', 'interventionNames': ['Drug: Inhaled Loxapine 10 mg']}], 'interventions': [{'name': 'Inhaled Loxapine 10 mg', 'type': 'DRUG', 'otherNames': ['Staccato Loxapine 10 mg'], 'description': 'Staccato Loxapine 10 mg, single dose', 'armGroupLabels': ['Healthy nonsmokers', 'Healthy smokers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '47710', 'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'facility': 'Covance Clinical Research Unit, Inc.', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}], 'overallOfficials': [{'name': 'Randall R. Stoltz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Covance Clincial Research Unit, 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'}}}}