Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2026-01-07 @ 1:10 AM
Study NCT ID:
NCT04157933
Status:
COMPLETED
Last Update Posted:
2020-11-04
First Post:
2019-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Staccato Apomorphine Multi-dose PK and PD in Patients With Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003434', 'term': 'Crossing Over, Genetic'}], 'ancestors': [{'id': 'D059765', 'term': 'Homologous Recombination'}, {'id': 'D011995', 'term': 'Recombination, Genetic'}, {'id': 'D055614', 'term': 'Genetic Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "This study will be conducted in subjects with established Parkinson's disease in 2 parts. Part A will examine the tolerability, safety, and pharmacokinetics of AZ-009 dose escalation ; and Part B will assess the tolerability, safety, pharmacokinetics, and pharmacodynamics of AZ-009 compared with placebo in a crossover design"}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2020-03-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-03', 'studyFirstSubmitDate': '2019-11-01', 'studyFirstSubmitQcDate': '2019-11-07', 'lastUpdatePostDateStruct': {'date': '2020-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'A - Dose Proportionality of multi-dose inhaled apomorphine by Power Analysis of AUC', 'timeFrame': '6 days', 'description': "Dose proportionality of inhaled Staccato apomorphine AUC across all 3 doses during Days 1-5 and multiple daily dosing (all 3 doses q 2 hr per day) on Day 6 using a power model \\[regression of log(AUC) versus log(dose)\\] in subjects with established Parkinson's disease"}, {'measure': "B1 - Effect on MDS-UPDRS in Parkinson's disease OFF periods", 'timeFrame': '2 days', 'description': "Explore in a crossover design on consecutive days the pharmacodynamics of AZ-009 compared with placebo on the Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III in subjects with established Parkinson's disease experiencing regular OFF episodes."}, {'measure': "B2 - Effect on Physician Disease State Assessment in Parkinson's disease OFF periods", 'timeFrame': '2 days', 'description': "Explore in a crossover design on consecutive days the pharmacodynamics of AZ-009 compared with placebo on the Physician Disease State Assessment in subjects with established Parkinson's disease experiencing regular OFF episodes."}, {'measure': "B3 - Effect on Patient Assessment of ON/OFF in Parkinson's disease OFF periods", 'timeFrame': '2 days', 'description': "Explore in a crossover design on consecutive days the pharmacodynamics of AZ-009 compared with placebo on Patient Assessment of ON/OFF in subjects with established Parkinson's disease experiencing regular OFF episodes."}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ["Parkinson's Disease"]}, 'descriptionModule': {'briefSummary': "This study will be conducted in subjects with established Parkinson's disease in 2 parts. Part A will examine the tolerability, safety, and pharmacokinetics of AZ-009 dose escalation ; and Part B will assess the tolerability, safety, pharmacokinetics, and pharmacodynamics of AZ-009 compared with placebo in a crossover design", 'detailedDescription': "This study will be conducted in subjects with established Parkinson's disease in 2 parts.\n\nPart A will examine the tolerability, safety, and pharmacokinetics of daily doses of AZ-009 for 5 days followed by 3 doses on each of days 6 and 7 in dose escalation through 3 cohorts\n\nPart B will assess the tolerability, safety, pharmacokinetics, and pharmacodynamics of AZ-009 compared with placebo in subjects with established Parkinson's disease experiencing regular OFF episodes"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy adult males and females between 30 and 85 years of age, inclusive at the time of signing the informed consent document with a clinical diagnosis of Parkinson's Disease\n* Body weight ≥ 50 kg and BMI within the range of 18 to 32 kg/m2.\n* Willing and able to be confined at the clinical research center for the study period and adhere to overall study visit schedule, procedures and other protocol requirements.\n* Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted.\n\nExclusion Criteria:\n\n* Any significant medical condition, psychiatric illness or history of depression that could, in the investigator's opinion, compromise the subject's safety or interfere with the completion of this protocol.\n* History of clinically significant central nervous system, cardiac, pulmonary, metabolic, renal, hepatic, or gastrointestinal conditions including gastric bypass or other weight loss"}, 'identificationModule': {'nctId': 'NCT04157933', 'briefTitle': "Staccato Apomorphine Multi-dose PK and PD in Patients With Parkinson's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Alexza Pharmaceuticals, Inc.'}, 'officialTitle': "A Placebo-Controlled, Double-Blind, Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Profile of AZ-009 in Subjects With Established Parkinson's Disease", 'orgStudyIdInfo': {'id': 'AMDC-009-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A-1a', 'description': 'Part A, Arm 1 (active), Dose 1 (009-A1)', 'interventionNames': ['Drug: 009-A1']}, {'type': 'EXPERIMENTAL', 'label': 'A-2a', 'description': 'Part A, Arm 2 (active), Dose 2 (009-A2)', 'interventionNames': ['Drug: 009-A2']}, {'type': 'EXPERIMENTAL', 'label': 'A-3a', 'description': 'Part A, Arm 3 (active), Dose 3 (009-A3)', 'interventionNames': ['Drug: 009-A3']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'A-0p', 'description': 'Part A, placebo comparator in all 3 arms, placebo dose (009-A0)', 'interventionNames': ['Drug: 009-A0']}, {'type': 'EXPERIMENTAL', 'label': 'B-1 (009-B3 -> 009-B0)', 'description': 'Crossover (active to placebo)', 'interventionNames': ['Drug: 009-B1 (active --> placebo) crossover']}, {'type': 'EXPERIMENTAL', 'label': 'B-1 (009-B0 -> 009-B3)', 'description': 'Crossover (placebo to active)', 'interventionNames': ['Drug: 009-B2 (placebo --> active) crossover']}], 'interventions': [{'name': '009-A1', 'type': 'DRUG', 'description': 'Inhaled apomorphine via Staccato aerosol, Dose 1 (low dose) each day for first 5 days, then 3 doses Dose 1 (low dose) q 2 hr on Day 6', 'armGroupLabels': ['A-1a']}, {'name': '009-A2', 'type': 'DRUG', 'description': 'Inhaled apomorphine via Staccato aerosol, Dose 2 (middle dose) each day for first 5 days, then 3 doses Dose 2 (middle dose) q 2 hr on Day 6', 'armGroupLabels': ['A-2a']}, {'name': '009-A3', 'type': 'DRUG', 'description': 'Inhaled apomorphine via Staccato aerosol, Dose 3 (high dose) each day for first 5 days, then 3 doses Dose 3 (high dose) q 2 hr on Day 6', 'armGroupLabels': ['A-3a']}, {'name': '009-A0', 'type': 'DRUG', 'description': 'Inhaled placebo via Staccato aerosol, Dose 0 (placebo) each day for first 5 days, then 3 doses Dose 0 (placebo) q 2 hr on Day 6', 'armGroupLabels': ['A-0p']}, {'name': '009-B1 (active --> placebo) crossover', 'type': 'DRUG', 'description': 'Up to 2 doses (Dose 3) ; minimum of 2 hrs between doses, on Day 1, followed by Up to 2 doses (placebo) ; minimum of 2 hrs between doses, on Day 2', 'armGroupLabels': ['B-1 (009-B3 -> 009-B0)']}, {'name': '009-B2 (placebo --> active) crossover', 'type': 'DRUG', 'description': 'Up to 2 doses (placebo) ; minimum of 2 hrs between doses, on Day 1, followed by Up to 2 doses (Dose 3) ; minimum of 2 hrs between doses, on Day 2', 'armGroupLabels': ['B-1 (009-B0 -> 009-B3)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2333', 'city': 'Leiden', 'country': 'Netherlands', 'facility': 'Centre for Human Drug Research', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}], 'overallOfficials': [{'name': 'Geert J Groeneveld, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center for Human Drug Research (The Netherlands)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexza Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}