Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2025-12-28 @ 5:54 AM
Study NCT ID:
NCT01241669
Status:
COMPLETED
Last Update Posted:
2014-07-11
First Post:
2010-11-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized, Placebo-controlled Study to Evaluate Effects of E5555 on Renal Function Parameters and OCT2 Activity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C540445', 'term': 'E 5555'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'lastUpdateSubmitDate': '2014-07-10', 'studyFirstSubmitDate': '2010-11-15', 'studyFirstSubmitQcDate': '2010-11-15', 'lastUpdatePostDateStruct': {'date': '2014-07-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the effects of multiple doses of E5555 on single dose pharmacokinetics of metformin.', 'timeFrame': '15 days'}], 'secondaryOutcomes': [{'measure': 'To assess the effects of multiple doses of E5555 on the glomerular filtration rate estimated using iohexol.', 'timeFrame': 'Days 7 and 14'}, {'measure': 'To assess the effects of multiple doses of E5555 on the effective renal plasma flow estimated using para-aminohippuric acid (PAH).', 'timeFrame': 'Days 7 and 14'}, {'measure': 'To assess the multiple dose pharmacokinetics of E5555 and its main 6 metabolites.', 'timeFrame': 'Days 12-18'}, {'measure': 'To assess the safety and tolerability of multiple doses of E5555 and a single dose of metformin either given alone or concomitantly', 'timeFrame': 'Day 1 - Day 18'}]}, 'conditionsModule': {'conditions': ['Healthy Subjects']}, 'descriptionModule': {'briefSummary': 'This is a drug-drug interaction study to evaluate the effects of steady-state exposure of E5555 and its main metabolites on the pharmacokinetics (PK) of metformin, an organic cation transporter-2 (OCT2) substrate. In addition, the study will also investigate the effects of E5555 on several renal function parameters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Healthy male or female subjects aged greater than or equal to 18 years to 55 years\n\nExclusion Criteria:\n\n* History of any medical condition which will result in an increased risk of bleeding including but not limited to active or recurrent gastric ulcers, recent head trauma or surgery, severe hypertension, bacterial endocarditis, etc.\n* Creatinine clearance \\< 90 mL/min as estimated using Cockcroft-Gault formula at screening or baseline\n* History of any renal disorders, proteinuria, hepato-biliary disease.'}, 'identificationModule': {'nctId': 'NCT01241669', 'briefTitle': 'Randomized, Placebo-controlled Study to Evaluate Effects of E5555 on Renal Function Parameters and OCT2 Activity', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eisai Inc.'}, 'officialTitle': 'A Single-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of Multiple Doses of E5555 on the Pharmacokinetics of Metformin (a Substrate for OCT2 Transporter) and on Renal Function in Healthy Subjects', 'orgStudyIdInfo': {'id': 'E5555-A001-023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'interventionNames': ['Drug: E5555']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2', 'interventionNames': ['Drug: E5555']}], 'interventions': [{'name': 'E5555', 'type': 'DRUG', 'description': 'Drug: Oral E5555 400 mg/matching placebo, oral metformin 500 mg, iohexal 20 mL intravenous (IV), and para-aminohippuric acid (PAH) 7 mg/kg IV.', 'armGroupLabels': ['Arm 1']}, {'name': 'E5555', 'type': 'DRUG', 'description': 'Drug: Oral E5555 100 mg/matching placebo, oral metformin 500 mg, iohexal 20 mL intravenous (IV), and para-aminohippuric acid (PAH) 7 mg/kg IV bolus.', 'armGroupLabels': ['Arm 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '661200', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Quintiles Phase I Services', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}], 'overallOfficials': [{'name': 'Dr. Bhaskar Rege', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eisai Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eisai Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}