Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:08 AM
Study NCT ID:
NCT00596518
Status:
COMPLETED
Last Update Posted:
2017-03-10
First Post:
2008-01-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Blood Levels, Safety, and Tolerability of PF-00734200 in Subjects With Impaired Kidney Function and Normal Kidney Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C558848', 'term': 'gosogliptin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-07', 'studyFirstSubmitDate': '2008-01-08', 'studyFirstSubmitQcDate': '2008-01-08', 'lastUpdatePostDateStruct': {'date': '2017-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-01-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the curve from time 0 until last observation (AUCtlast)', 'timeFrame': '3-6 days'}, {'measure': 'Maximum serum concentration (Cmax)', 'timeFrame': '3-6 days'}], 'secondaryOutcomes': [{'measure': 'AUC extrapolated to infinity (AUCinf)', 'timeFrame': '3-6 days'}, {'measure': 'Time of Cmax (Tmax)', 'timeFrame': '3-6 days'}, {'measure': 'Half life (T1/2)', 'timeFrame': '3-6 days'}, {'measure': 'Renal clearance (CLr)', 'timeFrame': '3-6 days'}, {'measure': 'Hemodialysis clearance (CLd)', 'timeFrame': '3 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Renal Insufficiency, Chronic']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare how PF-00734200 is adsorbed, distributed, broken down and eliminated by subjects with mild, moderate and severe kidney impairment, by subjects receiving chronic hemodialysis, and by subjects with normal kidney function. The removal rate of PF-00734200 by hemodialysis will be calculated. The safety and tolerability of PF-00734200 in subjects with various degrees of kidney function or undergoing chronic hemodialysis will be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '77 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects must meet one of the following renal function categories Normal renal function Mild renal impairment Moderate renal impairment End stage renal disease requiring chronic hemodialysis\n2. Body mass index between approximately 18-40 kg/m2 inclusive, and a total body weight greater than 50 kg\n3. Subjects in the normal renal function category must be healthy and not receiving any chronic treatment with prescription or non-prescription medications\n\nExclusion Criteria:\n\n1. Women who are pregnant, nursing or women of childbearing potential\n2. Subjects with acute renal disease.'}, 'identificationModule': {'nctId': 'NCT00596518', 'briefTitle': 'A Study to Evaluate the Blood Levels, Safety, and Tolerability of PF-00734200 in Subjects With Impaired Kidney Function and Normal Kidney Function', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 1, Open-Label Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of PF-00734200 Administered To Subjects With Various Degrees Of Renal Impairment And Normal Renal Function', 'orgStudyIdInfo': {'id': 'A7941014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PF-00734200', 'interventionNames': ['Drug: PF-00734200']}], 'interventions': [{'name': 'PF-00734200', 'type': 'DRUG', 'description': 'The drug is administered as a single dose of four 5-mg tablets', 'armGroupLabels': ['PF-00734200']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33169', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32809', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '55404', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '37920', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}