Ignite Creation Date:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2025-12-26 @ 11:14 AM
Study NCT ID:
NCT00736528
Status:
TERMINATED
Last Update Posted:
2009-02-25
First Post:
2008-08-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase I, Multiple Dose Study of PF-04447943 in Healthy Elderly Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'whyStopped': 'See Detailed Description for termination reason.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-02-23', 'studyFirstSubmitDate': '2008-08-15', 'studyFirstSubmitQcDate': '2008-08-15', 'lastUpdatePostDateStruct': {'date': '2009-02-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Safety: Adverse events, change from baseline in vital signs, triplicate ECG, clinical safety laboratory endpoints', 'timeFrame': '14 days'}, {'measure': 'Pharmacokinetic endpoints will include plasma PF 04447943 AUCt, Cmax and Tmax', 'timeFrame': '14 days'}], 'secondaryOutcomes': [{'measure': 'Changes in cognition from baseline', 'timeFrame': '14 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['safety, tolerability, pharmacokinetics, cognition'], 'conditions': ['Healthy', 'Elderly']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B0401002&StudyName=A%20phase%20I%2C%20multiple%20dose%20study%20of%20PF-04447943%20in%20healthy%20elderly%20volunteers', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'To describe the safety, tolerability and pharmacokinetics of PF-04447943 after administration of multiple, ascending, oral doses to healthy elderly subjects.', 'detailedDescription': 'Additional Study Purpose Details: Phase I safety and pharmacokinetics study.\n\nDetailed Description:\n\nThe study was terminated on 11/12/2008. There were no safety findings in this trial that resulted in the decision to terminate the trial. The study was closed in order to change the amount of drug that subjects would take and to shorten the number of days that the drug would be taken in a new study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy\n* Elderly\n* 65-85\n\nExclusion Criteria:\n\n* Evidence or history of clinically significant unstable disease'}, 'identificationModule': {'nctId': 'NCT00736528', 'briefTitle': 'A Phase I, Multiple Dose Study of PF-04447943 in Healthy Elderly Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'An Investigator And Subject-Blind, Phase 1 Study To Characterize The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Multiple Doses Of PF-04447943 In Healthy Elderly Subjects', 'orgStudyIdInfo': {'id': 'B0401002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PF-04447943 05 mg dose', 'interventionNames': ['Drug: PF-04447943']}, {'type': 'EXPERIMENTAL', 'label': 'PF-04447943 15 mg dose', 'interventionNames': ['Drug: PF-04447943']}, {'type': 'EXPERIMENTAL', 'label': 'PF-04447943 45 mg dose', 'interventionNames': ['Drug: PF-04447943']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'PF-04447943', 'type': 'DRUG', 'description': '05 mg BID for 14 days', 'armGroupLabels': ['PF-04447943 05 mg dose']}, {'name': 'PF-04447943', 'type': 'DRUG', 'description': '15 mg BID for 14 days', 'armGroupLabels': ['PF-04447943 15 mg dose']}, {'name': 'PF-04447943', 'type': 'DRUG', 'description': '45mg BID for 14 days', 'armGroupLabels': ['PF-04447943 45 mg dose']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo for 14 days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32608', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], '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.'}}}}