Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2026-02-26 @ 11:05 AM
Study NCT ID:
NCT02647918
Status:
COMPLETED
Last Update Posted:
2019-02-26
First Post:
2015-12-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate Sotagliflozin in Subjects With Varying Degrees of Renal Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-25', 'studyFirstSubmitDate': '2015-12-30', 'studyFirstSubmitQcDate': '2016-01-05', 'lastUpdatePostDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of treatment emergent adverse events', 'timeFrame': 'Day 1 to Day 8'}], 'secondaryOutcomes': [{'measure': 'Plasma concentration of sotaglifozin to evaluate AUC', 'timeFrame': 'Day 1'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Renal Impairment', 'Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of mild, moderate, or severe renal impairment, or end-stage renal disease (ESRD) requiring hemodialysis (HD), on the safety and tolerability of 1 or 2 single doses of sotagliflozin compared with healthy, demographically-matched subjects with normal renal function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult male and female subjects ≥18 to ≤75 years of age\n* Body mass index ≥18.0 to ≤36.0 kg/m2, at Screening\n* Subjects with mild, moderate, or severe renal impairment, or ESRD requiring HD\n* Control group of matched healthy subjects\n* Willing and able to provide written informed consent\n\nExclusion Criteria:\n\n* Presence of clinically significant physical, laboratory, or ECG findings that may interfere with any aspect of study conduct or interpretation of results\n* Existence of any surgical or medical condition that might interfere with the absorption, distribution, metabolism, or excretion of sotagliflozin\n* History of any major surgery within 6 months\n* History of hepatic disease, or significantly abnormal liver function test\n* Women who are breastfeeding or are planning to become pregnant during the study'}, 'identificationModule': {'nctId': 'NCT02647918', 'briefTitle': 'Study to Evaluate Sotagliflozin in Subjects With Varying Degrees of Renal Function', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lexicon Pharmaceuticals'}, 'officialTitle': 'A Phase 1, Open-label, Parallel-group Study to Evaluate Sotagliflozin Safety and Pharmacokinetics in Subjects With Varying Degrees of Renal Function', 'orgStudyIdInfo': {'id': 'LX4211.1-121-REN'}, 'secondaryIdInfos': [{'id': 'LX4211.121', 'type': 'OTHER', 'domain': 'Lexicon Pharmaceuticals, Inc.'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'Subjects with normal renal function', 'interventionNames': ['Drug: Sotagliflozin']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': 'Subjects with mild renal impairment', 'interventionNames': ['Drug: Sotagliflozin']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3', 'description': 'Subjects with moderate renal impairment', 'interventionNames': ['Drug: Sotagliflozin']}, {'type': 'EXPERIMENTAL', 'label': 'Group 4', 'description': 'Subjects with severe renal impairment', 'interventionNames': ['Drug: Sotagliflozin']}, {'type': 'EXPERIMENTAL', 'label': 'Group 5', 'description': 'Subjects with ESRD requiring HD', 'interventionNames': ['Drug: Sotagliflozin']}], 'interventions': [{'name': 'Sotagliflozin', 'type': 'DRUG', 'description': 'Single dose', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3', 'Group 4']}, {'name': 'Sotagliflozin', 'type': 'DRUG', 'description': '2 single doses', 'armGroupLabels': ['Group 5']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33014', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Lexicon Investigational Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32809', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Lexicon Investigational Site', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '55404', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Lexicon Investigational Site', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55114', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Lexicon Investigational Site', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}], 'overallOfficials': [{'name': 'Suman Wason, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Lexicon Pharmaceuticals, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lexicon Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}