Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-26 @ 12:27 AM
Study NCT ID:
NCT03809260
Status:
COMPLETED
Last Update Posted:
2020-10-08
First Post:
2019-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Trial for Analysis of Intestinal Microbiome Affecting PK, PD, and Safety of Metformin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}, {'id': 'D014640', 'term': 'Vancomycin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006020', 'term': 'Glycopeptides'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-06', 'studyFirstSubmitDate': '2019-01-08', 'studyFirstSubmitQcDate': '2019-01-16', 'lastUpdatePostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare the gut microbiome species change', 'timeFrame': 'Day 1/4/16/19', 'description': 'Compare how the gut microbiome species change after metformin (or vancomycin) multiple dosing'}], 'secondaryOutcomes': [{'measure': 'Compare the maximum plasma concentration (Cmax) of metformin', 'timeFrame': 'Day 4/19 (pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours post-dose)', 'description': 'Compare the maximum plasma concentration (Cmax) of metformin before and after vancomycin PO treatment'}, {'measure': 'Compare the area under the plasma concentration versus time curve (AUC) of metformin', 'timeFrame': 'Day 4/19 (pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours post-dose)', 'description': 'Compare the area under the plasma concentration versus time curve (AUC) of metformin before and after vancomycin PO treatment'}, {'measure': 'Compare the maximum blood glucose concentration (Gmax)', 'timeFrame': 'Day 1/4/16/19 (pre-dose (75 g glucose), 0.25, 0.5, 0.75, 1, 1.5. 2 hours)', 'description': 'Oral glucose tolerance test (OGTT); Compare the maximum blood glucose concentration (Gmax) before and after metformin (or vancomycin) PO treatment'}, {'measure': 'Compare the area under the blood glucose concentration versus time curve (AUC)', 'timeFrame': 'Day 1/4/16/19 (pre-dose (75 g glucose), 0.25, 0.5, 0.75, 1, 1.5. 2 hours)', 'description': 'Oral glucose tolerance test (OGTT); Compare the area under the blood glucose concentration versus time curve (AUC) before and after metformin (or vancomycin) PO treatment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Human Microbiome']}, 'referencesModule': {'references': [{'pmid': '33982376', 'type': 'DERIVED', 'citation': 'Kim E, Kim AH, Lee Y, Ji SC, Cho JY, Yu KS, Chung JY. Effects of vancomycin-induced gut microbiome alteration on the pharmacodynamics of metformin in healthy male subjects. Clin Transl Sci. 2021 Sep;14(5):1955-1966. doi: 10.1111/cts.13051. Epub 2021 May 31.'}]}, 'descriptionModule': {'briefSummary': 'This clinical trial is intended to evaluate the effects of the changes in intestinal microbiome by antibiotics (PO vancomycin) on the pharmacokinetic /pharmacodynamic and safety profiles of metformin in healthy male volunteers.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age between 19 to 45, healthy male subjects(at screening)\n* Body weight between 50.0 kg - 100.0 kg, BMI between 18.0 - 28.0 kg/m2\n* Subject who totally understand the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress.\n\nExclusion Criteria:\n\n* Subject who has a past or present history of any diseases following below.(liver, kidney, neurology, immunology, pulmonary, endocrine, hematology, oncology, cardiology, mental disorder)\n* Subject who had GI tract disease(Crohn's disease, ulcer, acute or chronic pancreatitis) or surgery (appendectomy, hernioplasty are excluded)\n* Serum AST(SGOT), ALT(SGPT)\\>1.5 times upper limit of normal range\n* MDRD eGFR \\<80mL/min/1.73m2\n* Subject who had drug (Aspirin, antibiotics) hypersensitivity reaction\n* Subject who already participated in other trials in 3 months\n* Subject who had whole blood donation in 2 months, or component blood donation in 1 month or transfusion in 1 month currently."}, 'identificationModule': {'nctId': 'NCT03809260', 'briefTitle': 'A Clinical Trial for Analysis of Intestinal Microbiome Affecting PK, PD, and Safety of Metformin', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'A Clinical Trial for Analysis of Intestinal Microbiome Affecting Pharmacokinetics, Pharmacodynamics, and Safety of Metformin in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'MMP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1', 'description': 'Metformin/Vancomycin', 'interventionNames': ['Drug: Metformin (part 1)', 'Drug: Vancomycin']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2', 'description': 'Metformin', 'interventionNames': ['Drug: Metformin (part 2)']}], 'interventions': [{'name': 'Metformin (part 1)', 'type': 'DRUG', 'otherNames': ['Diabex Tab., 500 mg'], 'description': '1\\~4d: Metformin 1000 mg bid (Except for 500 mg after 1d lunch), 16d\\~19d: Metformin 1000 mg bid (Except for 500 mg after 16d lunch).', 'armGroupLabels': ['Part 1']}, {'name': 'Vancomycin', 'type': 'DRUG', 'otherNames': ['Vancozin cap., 250 mg'], 'description': '11d: Vancomycin 250 mg bid, 12\\~17d: Vancomycin 500 mg bid', 'armGroupLabels': ['Part 1']}, {'name': 'Metformin (part 2)', 'type': 'DRUG', 'otherNames': ['Diabex Tab., 500 mg'], 'description': '1\\~4d: Metformin 1000 mg bid (Except for 500 mg after 1d lunch)', 'armGroupLabels': ['Part 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'SNUBH Clinical trial centor', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'overallOfficials': [{'name': 'Jae-Yong Chung', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Bundang Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jae Yong Chung, MD, PhD', 'investigatorAffiliation': 'Seoul National University Bundang Hospital'}}}}