Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2026-03-02 @ 6:24 PM
Study NCT ID:
NCT00555412
Status:
COMPLETED
Last Update Posted:
2017-03-15
First Post:
2007-11-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Staccato Loxapine Multidose PK
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': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-13', 'studyFirstSubmitDate': '2007-11-06', 'studyFirstSubmitQcDate': '2007-11-06', 'lastUpdatePostDateStruct': {'date': '2017-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-11-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PK parameters: tmax, Cmax, AUClast, AUCinf, ke, t1/2 and clearance will be estimated for each subject and for the population using noncompartmental methods.', 'timeFrame': '48 hours'}], 'secondaryOutcomes': [{'measure': 'Plasma concentration-time (PK) profiles will be produced for each subject and a mean PK profile for subjects completing for each dose group', 'timeFrame': '24 hours'}, {'measure': 'Tolerability will be assessed based on treatment emergent adverse events, vital signs, ECG and a visual-analog sedation scale.', 'timeFrame': '24 hours'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pharmacokinetic', 'multidose', 'Staccato Loxapine'], 'conditions': ['Volunteers on Chronic, Stable Antipsychotic Regimens']}, 'referencesModule': {'references': [{'pmid': '25808074', 'type': 'BACKGROUND', 'citation': 'Spyker DA, Riesenberg RA, Cassella JV. Multiple dose pharmacokinetics of inhaled loxapine in subjects on chronic, stable antipsychotic regimens. J Clin Pharmacol. 2015 Sep;55(9):985-94. doi: 10.1002/jcph.502. Epub 2015 May 6.'}]}, 'descriptionModule': {'briefSummary': 'The objectives of this trial are to assess the safety, tolerability, and pharmacokinetics of multiple inhaled doses of Staccato Loxapine.', 'detailedDescription': 'The purpose of the present Phase 1 study in schizophrenic patients is to assess the safety and pharmacokinetics of multiple doses of Staccato Loxapine given within a 24 hour time period. The study will be conducted in schizophrenic patients who are on chronic, stable antipsychotic medication. Patients meeting entry criteria will be randomized to one of three dose sequences of Staccato Loxapine or to Staccato Placebo. Following administration of medications, safety, tolerability and pharmacokinetic assessments will be conducted at serial time points.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria include:\n\n1. Male and female subjects between the ages of 18 to 65 years, inclusive.\n2. Subjects who are on stable, oral, chronic (\\>2 mos) antipsychotic medication regimen and who are able to tolerate the rapid oral dose taper and substitution regimen.\n\nExclusion Criteria include:\n\n1. Subjects who are currently treated with injectable depot neuroleptics within one dose interval must be excluded.\n2. Subjects who have received loxapine or amoxapine within the last 30 days must be excluded.\n3. Subjects with a history of allergy or intolerance to dibenzoxazepines (loxapine and amoxapine) must be excluded.\n4. Subjects with a history of movement disorders including Parkinson's disease or a history of neuroleptic malignant syndrome must be excluded.\n5. Subjects who have a history within the past year of drug or alcohol dependence or abuse as defined by DSM-4 must be excluded."}, 'identificationModule': {'nctId': 'NCT00555412', 'briefTitle': 'Staccato Loxapine Multidose PK', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alexza Pharmaceuticals, Inc.'}, 'officialTitle': 'Safety, Tolerability, and Pharmacokinetics of Multiple Doses of Staccato® Loxapine for Inhalation in Subjects on Chronic, Stable Antipsychotic Regimens', 'orgStudyIdInfo': {'id': 'AMDC-004-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A - 10 mg loxapine q 4 h x 3 (30 mg total)', 'interventionNames': ['Drug: A - 10 mg loxapine q 4 h x 3 (30 mg total)']}, {'type': 'EXPERIMENTAL', 'label': 'B - 10 mg x 1, 5 mg x 2 loxapine q 4 h (20 mg total)', 'interventionNames': ['Drug: B - 10 mg x 1, 5 mg x 2 loxapine q 4 h (20 mg total)']}, {'type': 'EXPERIMENTAL', 'label': 'C - 5 mg loxapine q 4 h x 3 (15 mg total)', 'interventionNames': ['Drug: C - 5 mg loxapine q 4 h x 3 (15 mg total)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'D - inhaled placebo q 4 h x 3', 'interventionNames': ['Drug: D - inhaled placebo q 4 h x 3']}], 'interventions': [{'name': 'A - 10 mg loxapine q 4 h x 3 (30 mg total)', 'type': 'DRUG', 'otherNames': ['Staccato Loxapine 10 mg'], 'description': 'loxapine aerosol inhalation high dose regimen (30 mg total)', 'armGroupLabels': ['A - 10 mg loxapine q 4 h x 3 (30 mg total)']}, {'name': 'B - 10 mg x 1, 5 mg x 2 loxapine q 4 h (20 mg total)', 'type': 'DRUG', 'otherNames': ['Staccato Loxapine 5 and 10 mg'], 'description': 'loxapine aerosol inhalation middle dose regimen (20 mg total)', 'armGroupLabels': ['B - 10 mg x 1, 5 mg x 2 loxapine q 4 h (20 mg total)']}, {'name': 'C - 5 mg loxapine q 4 h x 3 (15 mg total)', 'type': 'DRUG', 'otherNames': ['Staccato Loxapine 5 mg'], 'description': 'loxapine aerosol inhalation low dose regimen (15 mg total)', 'armGroupLabels': ['C - 5 mg loxapine q 4 h x 3 (15 mg total)']}, {'name': 'D - inhaled placebo q 4 h x 3', 'type': 'DRUG', 'otherNames': ['Staccato Placebo'], 'description': 'placebo aerosol inhalation (0 mg total)', 'armGroupLabels': ['D - inhaled placebo q 4 h x 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta Center for Medical Research', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Robert Riesenberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Atlanta Center for Medical Research'}]}, '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'}, 'collaborators': [{'name': 'Atlanta Center for Medical Research', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}