Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2025-12-30 @ 3:51 PM
Study NCT ID:
NCT00876304
Status:
COMPLETED
Last Update Posted:
2010-03-19
First Post:
2009-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multiple Dose Safety Study of PF-04802540 in 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-03-17', 'studyFirstSubmitDate': '2009-04-03', 'studyFirstSubmitQcDate': '2009-04-03', 'lastUpdatePostDateStruct': {'date': '2010-03-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety assessments: vital signs, ECG, physical examination, laboratory tests, Columbia - Suicide Severity Rating Scale', 'timeFrame': '22 days'}, {'measure': 'Adverse Events', 'timeFrame': '22 Days'}, {'measure': 'Plasma concentrations of PF 04802540 and its metabolite, PF 04831035', 'timeFrame': '12 Days'}], 'secondaryOutcomes': [{'measure': 'Positive and Negative Syndrome Scale', 'timeFrame': '16 days'}, {'measure': 'Clinical Global Impression of Severity and Improvement', 'timeFrame': '16 days'}, {'measure': 'Extrapyramidal Symptom Rating Scale - Abbreviated', 'timeFrame': '16 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PF-04802540 multiple dose safety study'], 'conditions': ['Schizophrenia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B0911004&StudyName=Multiple%20Dose%20Safety%20Study%20of%20PF-04802540%20in%20Subjects%20With%20Schizophrenia', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of multiple ascending doses of PF-04802540 administered orally to subjects with schizophrenia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males or females of non-childbearing capacity aged 18 to 55 years inclusive\n* DSM-IV diagnosis of schizophrenia, stable symptoms for at least 3 months\n* Body mass index in the range of 18 to 40 kg/m2 and body weight\\>45 kg.\n\nExclusion Criteria:\n\n* Evidence or history of a primary DSM IV axis I diagnosis other than schizophrenia.\n* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease\n* Any condition possibly affecting drug absorption (eg, gastrectomy).'}, 'identificationModule': {'nctId': 'NCT00876304', 'briefTitle': 'Multiple Dose Safety Study of PF-04802540 in Subjects With Schizophrenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Taisho Pharmaceutical Co., Ltd.'}, 'officialTitle': 'Phase 1, Investigator And Subject-Blind, Placebo-Controlled, Randomized, Sequential Group, Multiple Ascending Dose Study To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-04802540 In Patients With Schizophrenia', 'orgStudyIdInfo': {'id': 'B0911004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PF-04802540', 'interventionNames': ['Drug: PF-04802540']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'PF-04802540', 'type': 'DRUG', 'description': 'Multiple ascending doses for 10 days; planned doses include capsules totaling 5 mg and 20 mg every 12 hours, with additional doses determined based on accumulating data', 'armGroupLabels': ['PF-04802540']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo capsules every 12 hours for 10 days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91206', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taisho Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldOrganization': 'Taisho Pharmaceutical Co., Ltd.'}}}}