Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-31 @ 2:22 PM
Study NCT ID:
NCT01445860
Status:
COMPLETED
Last Update Posted:
2011-10-04
First Post:
2011-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drug-Drug Interaction Study Of Effect Of PF-03882845 On Simvastatin Pharmacokinetics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-09-30', 'studyFirstSubmitDate': '2011-07-11', 'studyFirstSubmitQcDate': '2011-09-30', 'lastUpdatePostDateStruct': {'date': '2011-10-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite (or Profile) of Pharmacokinetics', 'timeFrame': '15 days', 'description': 'AUCinf, AUClast, Cmax, Tmax, t1/2 of simvastatin and simvastatin acid'}], 'secondaryOutcomes': [{'measure': 'Number of patients with adverse events as a measure of safety.', 'timeFrame': '15 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['DDI', 'pharmacokinetics'], 'conditions': ['Human Volunteers']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B0171013&StudyName=Drug-Drug%20Interaction%20Study%20Of%20Effect%20Of%20PF-03882845%20On%20Simvastatin%20Pharmacokinetics', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to estimate the effect of multiple oral doses of PF-03882845 on the pharmacokinetics of simvastatin and simvastatin acid in healthy, adult subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy males and/or females of non-childbearing potential between the ages of 18 (or 21 based on country-specific age of consent) and 60 years, inclusive, at Screening. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG or clinical/safety laboratory tests.\n* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2 inclusive; and a total body weight \\>50 kg (110 lbs).\n\nExclusion Criteria:\n\n* Use of CYP3A4 inhibitors (eg, ketoconazole, ciprofloxacin, diltiazem) or inducers (eg, pheytoin, carbamazepine) or substrate (eg, simvastatin, quinidine) within 28 days or 5 half-lives (whichever is longer) prior to Day 1.\n* Known history of hypersensitivity, allergy, severe adverse drug reaction or intolerance to simvastatin or other statins.'}, 'identificationModule': {'nctId': 'NCT01445860', 'briefTitle': 'Drug-Drug Interaction Study Of Effect Of PF-03882845 On Simvastatin Pharmacokinetics', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 1, Open-Label, Fixed-Sequence Study To Estimate The Effect Of Repeated Dosing Of PF-03882845 On The Pharmacokinetics Of A Single Dose Of Simvastatin In Healthy Adult Subjects', 'orgStudyIdInfo': {'id': 'B0171013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'interventionNames': ['Drug: Simvastatin/PF-03882845']}], 'interventions': [{'name': 'Simvastatin/PF-03882845', 'type': 'DRUG', 'description': 'Single dose 20 mg simvastatin on Day 1, 30 mg PF-03882845 once daily from Days 2 to 13, the single dose 20 mg simvastatin on Day 12.', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '188770', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}