Ignite Creation Date:
2025-12-26 @ 11:47 AM
Ignite Modification Date:
2026-02-20 @ 6:25 PM
Study NCT ID:
NCT00645216
Status:
COMPLETED
Last Update Posted:
2009-08-10
First Post:
2008-03-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Examing The Effect of Grapefruit Juice On The Blood And Urine Samples of Study Drug And Its By Product And Safety
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-03', 'completionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-08-06', 'studyFirstSubmitDate': '2008-03-20', 'studyFirstSubmitQcDate': '2008-03-21', 'lastUpdatePostDateStruct': {'date': '2009-08-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of durg and metabolite concentrations in serum from blood sampling collected at various times over 24 hours dosing interval on Day 7 and 21, before dosing on days 5,6, 12, 13, 14, 19 and 20.', 'timeFrame': '21 days'}, {'measure': 'Safetey laboratory tests (chemistry, hematology, urinalysis) on Days -1 and 22', 'timeFrame': '21 days'}, {'measure': 'Adverse event monitoring throughout duration of the study', 'timeFrame': '21 days'}], 'secondaryOutcomes': [{'measure': 'Urinary 6-β-hydroxycortisol:cortisol ratios (CMR) on Days 0 and 21.', 'timeFrame': '2 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5351047&StudyName=Study%20Examing%20The%20Effect%20of%20Grapefruit%20Juice%20On%20The%20Blood%20And%20Urine%20Samples%20of%20Study%20Drug%20And%20Its%20By%20Product%20And%20Safety', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'CP-945,598 is eliminated primarily by enzyme CYP3A. Grapefruit juice may affect the activity of CYP3A and alter the amount of CP-945,598 in the blood. This study will therefore compare the time course of drug concentrations in the body, safety and tolerability of CP-945,598 given with or without grapefruit juice in healthy obese/overweight subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy male and female subjects between the ages of 18 and 55 years.\n2. Body Mass Index (BMI) of 27 to 40 kg/m2.\n3. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.\n\nExclusion Criteria:\n\n* Non-prescribed use of drugs of abuse/ recreational drugs;\n* Recent treatment with experimental drugs or herbal experiments;\n* EKG and blood pressure parameters falling outside of protocol-specified limits;\n* History of regular alcohol or tobacco use exceeding protocol-specified limits; grapefruit juice intolerance.'}, 'identificationModule': {'nctId': 'NCT00645216', 'briefTitle': 'Study Examing The Effect of Grapefruit Juice On The Blood And Urine Samples of Study Drug And Its By Product And Safety', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 1, Open Label, Randomized, Fixed Sequence Study To Evaluate The Effect Of Multiple Dose Administration Of Grapefruit Juice On The Multiple Dose Pharmacokinetics Of CP-945,598 In Healthy Overweight And Obese Subjects', 'orgStudyIdInfo': {'id': 'A5351047'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CP-945,598 with Grapefruit Juice', 'description': 'CP-945,598 with Grapefruit Juice', 'interventionNames': ['Drug: CP-945,598']}, {'type': 'EXPERIMENTAL', 'label': 'CP-945,598 alone', 'description': 'CP-945,598 alone', 'interventionNames': ['Drug: CP-945,598']}], 'interventions': [{'name': 'CP-945,598', 'type': 'DRUG', 'description': 'Subjects take CP-945,598 alone for 21 days', 'armGroupLabels': ['CP-945,598 alone']}, {'name': 'CP-945,598', 'type': 'DRUG', 'description': 'Subjects take CP-945,598 from Days 1 to 7, then take CP-945,598 and Grapefruit Juice from Days 8 to 21', 'armGroupLabels': ['CP-945,598 with Grapefruit Juice']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], '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.'}}}}