Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2026-03-08 @ 3:08 AM
Study NCT ID:
NCT02320032
Status:
COMPLETED
Last Update Posted:
2018-08-29
First Post:
2014-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open-Label Study of Aripiprazole Lauroxil in Subjects With Stable Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000603935', 'term': 'aripiprazole lauroxil'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-28', 'studyFirstSubmitDate': '2014-12-16', 'studyFirstSubmitQcDate': '2014-12-16', 'lastUpdatePostDateStruct': {'date': '2018-08-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC 0-last', 'timeFrame': 'Up to 45 weeks', 'description': 'Area under the plasma-concentration time curve from time zero to the last quantifiable plasma concentration'}, {'measure': 'C max', 'timeFrame': 'Up to 45 weeks', 'description': 'Maximum plasma concentration'}, {'measure': 'T max', 'timeFrame': 'Up to 45 weeks', 'description': 'Time to maximum plasma concentration'}], 'secondaryOutcomes': [{'measure': 'AUC 0-tau', 'timeFrame': 'Up to 45 weeks', 'description': 'Area under the plasma-concentration time curve over the dose interval'}, {'measure': 'Safety and tolerability will be measured by incidence of adverse events', 'timeFrame': 'Up to 45 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Alkermes', 'Schizophrenia', 'Aripiprazole', 'Aripiprazole lauroxil', 'ALKS 9072'], 'conditions': ['Schizophrenia']}, 'referencesModule': {'references': [{'pmid': '28350572', 'type': 'RESULT', 'citation': 'Hard ML, Mills RJ, Sadler BM, Turncliff RZ, Citrome L. Aripiprazole Lauroxil: Pharmacokinetic Profile of This Long-Acting Injectable Antipsychotic in Persons With Schizophrenia. J Clin Psychopharmacol. 2017 Jun;37(3):289-295. doi: 10.1097/JCP.0000000000000691.'}, {'pmid': '32621071', 'type': 'DERIVED', 'citation': 'Weiden PJ, Du Y, von Moltke L, Wehr A, Hard M, Marandi M, Walling DP. Pharmacokinetics, Safety, and Tolerability of a 2-Month Dose Interval Regimen of the Long-Acting Injectable Antipsychotic Aripiprazole Lauroxil: Results From a 44-Week Phase I Study. CNS Drugs. 2020 Sep;34(9):961-972. doi: 10.1007/s40263-020-00745-1.'}, {'pmid': '28597226', 'type': 'DERIVED', 'citation': 'Hard ML, Mills RJ, Sadler BM, Wehr AY, Weiden PJ, von Moltke L. Pharmacokinetic Profile of a 2-Month Dose Regimen of Aripiprazole Lauroxil: A Phase I Study and a Population Pharmacokinetic Model. CNS Drugs. 2017 Jul;31(7):617-624. doi: 10.1007/s40263-017-0447-7.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of various doses and dosing intervals of aripiprazole lauroxil.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has stable schizophrenia or schizoaffective disorder\n* Has demonstrated ability to tolerate aripiprazole\n* Has been on a stable antipsychotic medication regimen without any changes for at least 2 months prior to screening\n* Has a body mass index (BMI) of 18.0 to 35.0 kg/m2, inclusive\n* Additional criteria may apply\n\nExclusion Criteria:\n\n* Is pregnant, breastfeeding, or is planning to become pregnant during the study period\n* Has received aripiprazole lauroxil or IM depot aripiprazole within 6 months, or other long-acting, injectable antipsychotic medication within 3 months\n* Is a danger to himself/herself at screening or upon admission\n* Has a history of or positive test result for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C\n* Has a positive urine drug screen at screening or Day 1\n* Additional criteria may apply'}, 'identificationModule': {'nctId': 'NCT02320032', 'briefTitle': 'An Open-Label Study of Aripiprazole Lauroxil in Subjects With Stable Schizophrenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alkermes, Inc.'}, 'officialTitle': 'A Phase 1, Randomized, Open-Label Study Evaluating the Pharmacokinetics of Various Dosing Regimens of Aripiprazole Lauroxil in Subjects With Stable Schizophrenia', 'orgStudyIdInfo': {'id': 'ALK9072-A105'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aripiprazole Lauroxil - A', 'description': 'Intramuscular (IM) injection Dose and Dosing Sequence A', 'interventionNames': ['Drug: Aripiprazole Lauroxil']}, {'type': 'EXPERIMENTAL', 'label': 'Aripiprazole Lauroxil - B', 'description': 'Intramuscular (IM) injection Dose and Dosing Sequence B', 'interventionNames': ['Drug: Aripiprazole Lauroxil']}, {'type': 'EXPERIMENTAL', 'label': 'Aripiprazole Lauroxil - C', 'description': 'Intramuscular (IM) injection Dose and Dosing Sequence C', 'interventionNames': ['Drug: Aripiprazole Lauroxil']}, {'type': 'EXPERIMENTAL', 'label': 'Aripiprazole Lauroxil - D', 'description': 'Intramuscular (IM) injection Dose and Dosing Sequence D', 'interventionNames': ['Drug: Aripiprazole Lauroxil']}], 'interventions': [{'name': 'Aripiprazole Lauroxil', 'type': 'DRUG', 'description': 'Gluteal IM injection, given once every 4 to 8 weeks', 'armGroupLabels': ['Aripiprazole Lauroxil - A', 'Aripiprazole Lauroxil - B', 'Aripiprazole Lauroxil - C', 'Aripiprazole Lauroxil - D']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Alkermes Investigational Site', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90703', 'city': 'Cerritos', 'state': 'California', 'country': 'United States', 'facility': 'Alkermes Investigational Site', 'geoPoint': {'lat': 33.85835, 'lon': -118.06479}}, {'zip': '92845', 'city': 'Garden Grove', 'state': 'California', 'country': 'United States', 'facility': 'Alkermes Investigational Site', 'geoPoint': {'lat': 33.77391, 'lon': -117.94145}}, {'zip': '20016', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Alkermes Investigational Site', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33161', 'city': 'Lauderhill', 'state': 'Florida', 'country': 'United States', 'facility': 'Alkermes Investigational Site', 'geoPoint': {'lat': 26.14036, 'lon': -80.21338}}, {'zip': '34748', 'city': 'Leesburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Alkermes Investigational Site', 'geoPoint': {'lat': 28.81082, 'lon': -81.87786}}, {'zip': '32751', 'city': 'Maitland', 'state': 'Florida', 'country': 'United States', 'facility': 'Alkermes Investigational Site', 'geoPoint': {'lat': 28.62778, 'lon': -81.36312}}, {'zip': '33334', 'city': 'Oakland Park', 'state': 'Florida', 'country': 'United States', 'facility': 'Alkermes Investigational Site', 'geoPoint': {'lat': 26.17231, 'lon': -80.13199}}, {'zip': '33613', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Alkermes Investigational Site', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Alkermes Investigational Site', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60640', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Alkermes Investigational Site', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60169', 'city': 'Hoffman Estates', 'state': 'Illinois', 'country': 'United States', 'facility': 'Alkermes Investigational Site', 'geoPoint': {'lat': 42.04281, 'lon': -88.0798}}, {'zip': '63118', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Alkermes Investigational Site', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '8053', 'city': 'Marlton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Alkermes Investigational Site', 'geoPoint': {'lat': 39.89122, 'lon': -74.92183}}, {'zip': '78754', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Alkermes Investigational Site', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75243', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Alkermes Investigational Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Alkermes Medical Director, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alkermes, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alkermes, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}