Ignite Creation Date:
2025-12-24 @ 5:29 PM
Ignite Modification Date:
2026-04-21 @ 1:23 PM
Study NCT ID:
NCT02804568
Status:
COMPLETED
Last Update Posted:
2016-09-22
First Post:
2016-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 1 Safety Study in Adults With 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-21', 'studyFirstSubmitDate': '2016-06-15', 'studyFirstSubmitQcDate': '2016-06-15', 'lastUpdatePostDateStruct': {'date': '2016-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum plasma concentration (Cmax)', 'timeFrame': 'Up to 15 days of dosing'}, {'measure': 'Area under the concentration vs time curve over the 24 hour dosing interval (AUC0-24h)', 'timeFrame': 'Up to 15 days of dosing'}], 'secondaryOutcomes': [{'measure': 'Safety will be determined by incidence of drug-related adverse events', 'timeFrame': 'Up to 21 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Schizophrenia', 'Alkermes', 'ALK 3831', 'Samidorphan'], 'conditions': ['Schizophrenia']}, 'referencesModule': {'references': [{'pmid': '30348514', 'type': 'DERIVED', 'citation': 'Sun L, McDonnell D, von Moltke L. Pharmacokinetics and Short-term Safety of ALKS 3831, a Fixed-dose Combination of Olanzapine and Samidorphan, in Adult Subjects with Schizophrenia. Clin Ther. 2018 Nov;40(11):1845-1854.e2. doi: 10.1016/j.clinthera.2018.09.002. Epub 2018 Oct 20.'}]}, 'descriptionModule': {'briefSummary': 'This study will determine the safety, tolerability, and pharmacokinetics (PK) of olanzapine and samidorphan in adults with schizophrenia following 14 consecutive days of oral administration of ALKS 3831.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has a body mass index (BMI) of 18.0-35.0 kg/m\\^2, inclusive\n* Has a primary diagnosis of schizophrenia\n* Capable of understanding and complying with the procedures, requirements, and restrictions of the protocol.\n* Appropriate for outpatient treatment\n* Agrees to abide by the contraception requirements specified in the protocol for the duration of the study or is surgically sterile\n* Willing and able to provide government-issued identification\n* Is in good physical health\n* Agrees to maintain normal tobacco use as well as normal activities/exercise throughout the study\n* Additional criteria may apply\n\nExclusion Criteria:\n\n* Is currently pregnant or breastfeeding\n* Initiated first antipsychotic treatment within the past 12 months, or \\<1 year has elapsed since the initial onset of active-phase schizophrenia symptoms\n* Poses a current suicide risk at Visits 1 or 2\n* Has a history of poor or inadequate response to treatment with olanzapine\n* Has used a long-acting injectable antipsychotic medication in the last 6 months with the exception of 3-month paliperidone, which must not have been received within the past 12 months.\n* Requires or has had electroconvulsive therapy (ECT) treatment in the 6-month period prior to Visit 1\n* Has a diagnosis of alcohol or drug use disorder (with the exception of nicotine)\n* Has taken opioid agonists (codeine, oxycodone, tramadol, or morphine) within the 14 days prior to Visit 1 and/or anticipates a need to take opioid medication during the study period.\n* Has taken opioid antagonists including naltrexone (any formulations) and naloxone within 60 days prior to Visit 1, or has used any extended-release formulation of an opioid antagonist within 2 months prior to screening\n* Tests positive for amphetamines/methamphetamine, cocaine, barbiturates, opioids (codeine, hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxymorphone, and buprenorphine), phencyclidine and benzodiazepines.\n* Has a known or suspected intolerance, allergy or hypersensitivity to olanzapine or opioid antagonists.\n* Additional criteria may apply'}, 'identificationModule': {'nctId': 'NCT02804568', 'briefTitle': 'A Phase 1 Safety Study in Adults With Schizophrenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alkermes, Inc.'}, 'officialTitle': 'A Multiple-dose, Open-label Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ALKS 3831 in Adult Subjects With Schizophrenia', 'orgStudyIdInfo': {'id': 'ALK3831-A104'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'Olanzapine/samidorphan 10 mg/10 mg', 'interventionNames': ['Drug: ALKS 3831']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': 'Olanzapine/samidorphan 20 mg/10 mg', 'interventionNames': ['Drug: ALKS 3831']}], 'interventions': [{'name': 'ALKS 3831', 'type': 'DRUG', 'description': 'Oral capsule, daily administration', 'armGroupLabels': ['Group 1', 'Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Alkermes Investigational Site', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '08021', 'city': 'Clementon', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Alkermes Investigational Site', 'geoPoint': {'lat': 39.8115, 'lon': -74.98294}}, {'zip': '45417', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Alkermes Investigational Site', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}], 'overallOfficials': [{'name': 'David McDonnell, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alkermes, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alkermes, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}