Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2025-12-25 @ 5:22 PM
Study NCT ID:
NCT00959803
Status:
COMPLETED
Last Update Posted:
2009-12-07
First Post:
2009-08-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study Of Single Ascending And Multiple Doses Of PF-04447943 In Japanese Subjects.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C572323', 'term': '6-(4-methyl-1-(pyrimidin-2-ylmethyl)pyrrolidin-3-yl)-1-(tetrahydro-2H-pyran-4-yl)-1,5-dihydro-4H-pyrazolo(3,4-d)pyrimidin-4-one'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-12-03', 'studyFirstSubmitDate': '2009-08-13', 'studyFirstSubmitQcDate': '2009-08-14', 'lastUpdatePostDateStruct': {'date': '2009-12-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AEs (spontaneous and solicited). Change from baseline in vital signs.', 'timeFrame': 'Day 0 to follow up visit after Study Day 5(single dose arm) and Day 11(multiple dose arm)'}, {'measure': 'ECG and clinical safety laboratory endpoints, including a complete blood count, a full chemistry panel (including electrolytes and hepatic transaminases) and urinalysis.', 'timeFrame': 'Screening visit to follow up visit after Study Day 5(single dose arm) and Day 11(multiple dose arm)'}, {'measure': 'Pharmacokinetic (single): AUClast, Cmax, Tmax', 'timeFrame': 'Day 1 to day 5'}, {'measure': 'Pharmacokinetic(multiple): AUCt, Cmax and Tmax on Days 1 and 7, and Ctrough on Days 2, 3, 4 and 7.', 'timeFrame': 'Day 1 to day 11'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Phase 1', 'Pharmacokinetics', 'Healthy Young Adult', 'Japanese', 'Healthy Elderly', 'Alzheimer disease'], 'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B0401004&StudyName=Study%20Of%20Single%20Ascending%20And%20Multiple%20Doses%20Of%20PF-04447943%20In%20Japanese%20Subjects.', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to investigate the safety, tolerability, and pharmacokinetics of PF-04447943 after single and multiple-dose administration to healthy young adult and elderly Japanese subjects, respectively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* For young cohort, healthy male and/or female Japanese of non-child bearing potential between the age of 18 and 55 years, inclusive.\n* For elderly cohort, healthy male and/or female Japanese of non-child bearing potential between the age of 65 and 85 years, inclusive.\n* Body Mass Index (BMI) between 17.5 to 30.5 kg/m2, and a total body weight \\>50 kg (110 lbs).\n\nExclusion Criteria:\n\n* Pregnant or nursing women; women of childbearing potential.\n* Males who are unwilling to abstain from sexual intercourse or use a condom with all child-bearing potential women for the duration of the study.'}, 'identificationModule': {'nctId': 'NCT00959803', 'briefTitle': 'Study Of Single Ascending And Multiple Doses Of PF-04447943 In Japanese Subjects.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'An Investigator- And Subject-Blind Phase 1 Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of PF-04447943 After Administration Of Single Oral Doses To Healthy Young Adult Japanese Subjects And Multiple Oral Doses To Healthy Elderly Japanese Subjects', 'orgStudyIdInfo': {'id': 'B0401004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single dose', 'description': '3 way crossover with randomized placebo substitution to evaluate single escalating oral doses of PF 04447943 in 9 healthy young adult subjects.', 'interventionNames': ['Drug: PF-04447943', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Multiple dose', 'description': '3:1 active PF 04447943 to placebo randomization in 8 healthy elderly subjects.', 'interventionNames': ['Drug: PF-04447943', 'Drug: Placebo']}], 'interventions': [{'name': 'PF-04447943', 'type': 'DRUG', 'description': '3 mg solution, oral single dose.', 'armGroupLabels': ['Single dose']}, {'name': 'PF-04447943', 'type': 'DRUG', 'description': '10 mg solution, oral single dose.', 'armGroupLabels': ['Single dose']}, {'name': 'PF-04447943', 'type': 'DRUG', 'description': '25 mg solution, oral single dose.', 'armGroupLabels': ['Single dose']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Solution, oral single dose.', 'armGroupLabels': ['Single dose']}, {'name': 'PF-04447943', 'type': 'DRUG', 'description': '25 mg solution, oral twice daily for 7 days.', 'armGroupLabels': ['Multiple dose']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Solution, oral twice daily for 7 days.', 'armGroupLabels': ['Multiple dose']}]}, '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': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Director, Clinical Trial Disclosure Group', 'oldOrganization': 'Pfizer, Inc.'}}}}