Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-27 @ 11:08 PM
Study NCT ID:
NCT01518894
Status:
COMPLETED
Last Update Posted:
2019-11-21
First Post:
2012-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study To Examine The Safety, Tolerability And Pharmacokinetics Of PF-04958242 In Psychiatrically Stable Subjects 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000600968', 'term': 'PF-04958242'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-19', 'studyFirstSubmitDate': '2012-01-23', 'studyFirstSubmitQcDate': '2012-01-23', 'lastUpdatePostDateStruct': {'date': '2019-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite of Pharmacokinetics measured at 0.25, 0.5, 0.75, 1, 2, 3, 4, 8, 12, 24 hours after dosing on Day 1', 'timeFrame': 'Day 1 - Day 2'}, {'measure': 'Composite of Pharmacokinetics measured pre-dose and 1 hour post-dose on Day 4', 'timeFrame': 'Day 4'}, {'measure': 'Composite of Pharmacokinetics measured pre-dose and 1 hour post-dose on Day 7', 'timeFrame': 'Day 7'}, {'measure': 'Composite of Pharmacokinetics measured at 0.25, 0.5, 0.75, 1, 2, 3, 4, 8, 12, 24, 48, 72, 120 hours after dosing on Day 14', 'timeFrame': 'Day 14 - Day 17'}, {'measure': 'Composite of urine Pharmacokinetics measured for 24 hours post-dose on Day 14', 'timeFrame': 'Day 14 - Day 15'}], 'secondaryOutcomes': [{'measure': 'Cogntion - CogState', 'timeFrame': 'Day 0, 1, 6, 13'}, {'measure': 'Cognition - Matrics Consensus Cognition Battery', 'timeFrame': 'Day 0, 1, 6, 13'}, {'measure': 'Drug Effect Questionnaire liking scale', 'timeFrame': 'Day, 1, 14'}, {'measure': 'Cognitive training', 'timeFrame': 'Days 0 - 13'}, {'measure': 'Columbia Suicide Severity Rating Scale', 'timeFrame': 'Day 0, 1, 7, 14, 17, 23'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PF-04958242', 'multiple dose', 'Safety', 'schizophrenia'], 'conditions': ['Schizophrenia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1701004&StudyName=A%20Study%20To%20Examine%20The%20Safety%2C%20Tolerability%20And%20Pharmacokinetics%20Of%20%20PF-04958242%20In%20Psychiatrically%20Stable%20Subjects%20With%20Schizophrenia', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the safety and tolerability of multiple, ascending doses of PF-04958242 administered orally to psychiatrically stable subjects with schizophrenia receiving antipsychotic and adjunctive medication.', 'detailedDescription': 'This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Psychiatrically stable subjects with schizophrenia\n* Evidence of stable schizophrenia symptomatology ≥ 3 months\n* Score on MCCB Letter-number span + Spatial span subtest \\< 40.\n\nExclusion Criteria:\n\n* History of seizures or of a condition with risk of seizures\n* History of abnormal EEG.\n* Pregnant or nursing females, and women of child bearing potential'}, 'identificationModule': {'nctId': 'NCT01518894', 'briefTitle': 'A Study To Examine The Safety, Tolerability And Pharmacokinetics Of PF-04958242 In Psychiatrically Stable Subjects With Schizophrenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biogen'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo Controlled, Sponsor Open, Phase 1b Study To Examine The Safety, Tolerability And Pharmacokinetics Of PF-04958242 In Psychiatrically Stable Subjects With Schizophrenia', 'orgStudyIdInfo': {'id': 'B1701004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PF-04958242', 'interventionNames': ['Drug: PF-04958242']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'PF-04958242', 'type': 'DRUG', 'description': 'PF-04958242 0.10 mg oral solution Q24 hours for 14 days', 'armGroupLabels': ['PF-04958242']}, {'name': 'PF-04958242', 'type': 'DRUG', 'description': 'PF-04958242 0.20 mg oral solution Q24 hours for 14 days', 'armGroupLabels': ['PF-04958242']}, {'name': 'PF-04958242', 'type': 'DRUG', 'description': 'PF-04958242 oral solution Q24 hours for 14 days (dose to be determined)', 'armGroupLabels': ['PF-04958242']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo oral solution Q24 hours for 14 days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Biogen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biogen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}