Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2026-01-24 @ 3:58 PM
Study NCT ID:
NCT02125305
Status:
COMPLETED
Last Update Posted:
2014-04-29
First Post:
2014-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study to Investigate the Pharmacokinetics and Pharmacodynamics of Metformin in the Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'lastUpdateSubmitDate': '2014-04-28', 'studyFirstSubmitDate': '2014-04-25', 'studyFirstSubmitQcDate': '2014-04-28', 'lastUpdatePostDateStruct': {'date': '2014-04-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC(area under the plasma concentration-time curve)', 'timeFrame': 'Predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12h postdose', 'description': 'AUC(area under the plasma concentration-time curve), Cmax(maximum plasma concentration), t1/2'}], 'secondaryOutcomes': [{'measure': 'AUGC(total area under the serum concentration-time curve for glucose concentration)', 'timeFrame': 'predose and 15, 30, 45, 60, 90, 120 min oral glucose tolerance test', 'description': 'AUG (total area under the serum concentration-time curve for glucose) Gmax(maximum serum glucose concentration)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Metformin', 'Pharmacokinetics/ Pharmacodynamics'], 'conditions': ['Healthy Elderly']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the pharmacokinetics/pharmacodynamics metformin IR after oral administration in healthy elderly male volunteers.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males aged 65-85 years with a body mass index (BMI) of 18-28 kg/m2\n* Good health based on complete medical history, physical examinations, vital signs, electrocardiography (ECG), and clinical laboratory evaluations including hematology (blood cell count, hemoglobin, and platelet count), liver function test (aspartate aminotransferase (AST), alanine aminotransferase (ALT), and bilirubin), serum creatinine, blood glucose and urinalysis\n\nExclusion Criteria:\n\n* If they had clinically relevant disorders\n* Past history of diabetes or clinical findings to suspect diabetes\n* Abnormal clinical laboratory values (i.e., platelets ≤ 75,000/mm3, hemoglobin ≤ 9 g/dL, neutrophils absolute ≤ 1000/mm3, fasting glucose \\> 126mg/dL, creatinine ≥ 1.5 mg/dL, or AST, ALT \\> 3 × upper limit of normal)'}, 'identificationModule': {'nctId': 'NCT02125305', 'acronym': 'ME01', 'briefTitle': 'Clinical Study to Investigate the Pharmacokinetics and Pharmacodynamics of Metformin in the Elderly', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'A Phase I Clinical Study to Investigate the Pharmacokinetics and Pharmacodynamics of Metformin in Elderly Healthy Male Volunteers', 'orgStudyIdInfo': {'id': 'ME01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Metformin', 'description': 'Metformin 750mg(D1), Metformin 500mg(D2)', 'interventionNames': ['Drug: Metformin']}], 'interventions': [{'name': 'Metformin', 'type': 'DRUG', 'otherNames': ['Diabex'], 'armGroupLabels': ['Metformin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jae-Yong Chung, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University Bundang hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D., Ph.D', 'investigatorFullName': 'Jae Yong Chung', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}