Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2026-03-02 @ 4:23 PM
Study NCT ID:
NCT01369602
Status:
COMPLETED
Last Update Posted:
2012-02-22
First Post:
2011-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study To Evaluate The Effect Of Renal Impairment On The Pharmacokinetics Of PF-04991532
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C571532', 'term': '6-(3-cyclopentyl-2-(4-(trifluoromethyl)-1H-imidazol-1-yl)propanamido)nicotinic acid'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-21', 'studyFirstSubmitDate': '2011-06-07', 'studyFirstSubmitQcDate': '2011-06-07', 'lastUpdatePostDateStruct': {'date': '2012-02-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the plasma concentration versus time curve (AUClast)', 'timeFrame': '0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 hrs'}, {'measure': 'Maximum observed plasma concentration (Cmax)', 'timeFrame': '0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 hrs'}, {'measure': 'Time of maximum observed plasma concentration (Tmax)', 'timeFrame': '0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 hrs'}, {'measure': 'Renal Clearance (Clr)', 'timeFrame': '0 to 24 hours'}, {'measure': 'Amount of drug excreted (Ae)', 'timeFrame': '0 to 24 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus', 'Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B2611011&StudyName=Study%20To%20Evaluate%20The%20Effect%20Of%20Renal%20Impairment%20On%20The%20Pharmacokinetics%20Of%20PF-04991532', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of a single oral dose of PF-04991532 in subjects with renal impairment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stable renal function defined as \\<20% difference between two measurements of serum creatinine obtained on two occasions separated by at least 72 hours to 14 days; the second determination must be obtained within the 28-day period prior to the start of study medication administration. CrCl value at Screening (average of two values obtained within two weeks apart before dosing) will be used for study enrollment.\n* Body Mass Index (BMI) of 17.5 to 40 kg/m2; and a total body weight \\>50 kg (110 lbs).\n* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\n\nExclusion Criteria:\n\n* Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of nonhormonal contraception as outlined in this protocol from at least 14 days prior to the first dose of study medication.\n* Subjects with recent (within the last 6 months) history of myocardial infarction, unstable angina, coronary revascularization, stroke or transient ischemic attack (TIA).\n* Subjects with severe heart failure (New York Heart Association Functional Class IV) at Screening.\n* Subjects with acute renal disease.'}, 'identificationModule': {'nctId': 'NCT01369602', 'briefTitle': 'Study To Evaluate The Effect Of Renal Impairment On The Pharmacokinetics Of PF-04991532', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 1, Single-Dose, Open-Label Study To Evaluate The Effect Of Renal Impairment On The Pharmacokinetics Of PF-04991532', 'orgStudyIdInfo': {'id': 'B2611011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'healthy controls', 'description': 'healthy subjects (creatinine clearance \\> 90 mL/min)', 'interventionNames': ['Drug: PF-04991532']}, {'type': 'EXPERIMENTAL', 'label': 'ESRD / severe renal insufficiency', 'description': 'Severe (creatinine clearance 15 to 29 mL/min) OR ESRD (creatinine clearnace \\<15 mL/min OR requiring dialysis)', 'interventionNames': ['Drug: PF-04991532']}, {'type': 'EXPERIMENTAL', 'label': 'Moderate renal impairment', 'description': 'Moderate (creatinine clearance = 30 to 59 mL/min)', 'interventionNames': ['Drug: PF-04991532']}, {'type': 'EXPERIMENTAL', 'label': 'Mild renal impairment', 'description': 'Mild (creatinine clearance = 60 to 89 mL/min)', 'interventionNames': ['Drug: PF-04991532']}], 'interventions': [{'name': 'PF-04991532', 'type': 'DRUG', 'description': 'single dose 300-mg', 'armGroupLabels': ['healthy controls']}, {'name': 'PF-04991532', 'type': 'DRUG', 'description': 'single dose 300-mg', 'armGroupLabels': ['ESRD / severe renal insufficiency']}, {'name': 'PF-04991532', 'type': 'DRUG', 'description': 'single dose 300-mg', 'armGroupLabels': ['Moderate renal impairment']}, {'name': 'PF-04991532', 'type': 'DRUG', 'description': 'single dose 300-mg', 'armGroupLabels': ['Mild renal impairment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '32720', 'city': 'DeLand', 'state': 'Florida', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 29.02832, 'lon': -81.30312}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}