Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2025-12-27 @ 1:47 AM
Study NCT ID:
NCT01292993
Status:
COMPLETED
Last Update Posted:
2011-03-30
First Post:
2011-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Interaction of LX4211 and Metformin in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C575681', 'term': '(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol'}, {'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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'lastUpdateSubmitDate': '2011-03-29', 'studyFirstSubmitDate': '2011-02-08', 'studyFirstSubmitQcDate': '2011-02-09', 'lastUpdatePostDateStruct': {'date': '2011-03-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma concentration of LX4211 and metformin after concurrent single-dose administration', 'timeFrame': 'Up to 43 days, including screening'}], 'secondaryOutcomes': [{'measure': 'Urinary glucose excretion', 'timeFrame': 'Up to 43 days, including screening'}, {'measure': 'Fasting plasma glucose', 'timeFrame': 'Up to 43 days, including screening'}, {'measure': 'Postprandial glucose', 'timeFrame': 'Up to 43 days, including screening'}, {'measure': 'Insulin', 'timeFrame': 'Up to 43 days, including screening'}, {'measure': 'Peptide YY', 'timeFrame': 'Up to 43 days, including screening'}, {'measure': 'Glucagon-like peptide (GLP-1)', 'timeFrame': 'Up to 43 days, including screening'}, {'measure': 'Glucose-dependent insulinotropic peptide', 'timeFrame': 'Up to 43 days, including screening'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effects of LX4211 and metformin on each other when given at the same time as single doses to healthy human subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults ≥18 to ≤55 years of age. Females must be of non-childbearing potential.\n* Body mass index (BMI)≥18 to ≤35 kg/sq m\n* Able to provide written consent\n* Vital signs within sponsor-defined ranges\n\nExclusion Criteria:\n\n* Use of any medication, including any prescription, over-the-counter, herbal tea, or other supplements within 5 days of dosing\n* No investigational agent or study treatment within 30 days prior to Day 1.\n* No protein or antibody-based therapeutic agents within 3 months prior to screening\n* Use of any tobacco product\n* History of bariatric surgery or any gastrointestinal surgery that may induce malabsorption\n* History of any major surgery within 6 months prior to screening\n* History of any serious adverse reaction or hypersensitivity to metformin or LX4211.\n* History of renal disease or significantly abnormal kidney function test\n* History of hepatic disease or significantly abnormal liver function test\n* History of any active infection within 30 days prior to Day 1\n* History of any surgical or medical condition or clinically significant laboratory or physical finding\n* Positive urine glucose at Screening\n* Use of drugs or alcohol'}, 'identificationModule': {'nctId': 'NCT01292993', 'briefTitle': 'A Study to Evaluate the Interaction of LX4211 and Metformin in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lexicon Pharmaceuticals'}, 'officialTitle': 'A Phase 1, Randomized, Open-Label, 3-Period, 3-Treatment, Single-dose Crossover Study to Evaluate the Pharmacokinetic Interaction of LX4211 and Metformin in Healthy Subjects', 'orgStudyIdInfo': {'id': 'LX4211.1-103-DDI'}, 'secondaryIdInfos': [{'id': 'LX4211.103', 'type': 'OTHER', 'domain': 'Lexicon Pharmaceuticals, Inc.'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment A', 'description': '400 mg LX4211', 'interventionNames': ['Drug: 400 mg LX4211']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment B', 'description': '1000 mg metformin', 'interventionNames': ['Drug: 1000 mg metformin']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment C', 'description': '400 mg LX4211 + 1000 mg metformin', 'interventionNames': ['Drug: 400 mg LX4211', 'Drug: 1000 mg metformin']}], 'interventions': [{'name': '400 mg LX4211', 'type': 'DRUG', 'description': '400 mg of LX4211 given as a solid oral dose form', 'armGroupLabels': ['Treatment A', 'Treatment C']}, {'name': '1000 mg metformin', 'type': 'DRUG', 'description': '1000 mg metformin given as a solid oral dose form', 'armGroupLabels': ['Treatment B', 'Treatment C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78209', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Lexicon Investigational Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Ikenna Ogbaa, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Lexicon Pharmaceuticals, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lexicon Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Ikenna Ogbaa, MD', 'oldOrganization': 'Lexicon Pharmaceuticals, Inc.'}}}}