Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2026-02-19 @ 9:54 AM
Study NCT ID:
NCT03909451
Status:
COMPLETED
Last Update Posted:
2022-04-25
First Post:
2019-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sotagliflozin Multiple-dose Study in Healthy Chinese Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2019-08-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-22', 'studyFirstSubmitDate': '2019-04-08', 'studyFirstSubmitQcDate': '2019-04-08', 'lastUpdatePostDateStruct': {'date': '2022-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events (AEs)', 'timeFrame': 'Up to 41 days', 'description': 'Proportion of patients who experienced adverse events/treatment-emergent AEs (TEAE)'}], 'secondaryOutcomes': [{'measure': 'Assessment of PK parameter: Maximum plasma concentration (Cmax)', 'timeFrame': 'On Day 1 and from Day 8 to Day 13', 'description': 'Sotagliflozin and Sotagliflozin-O-glucuronide: Maximum plasma concentration (Cmax)'}, {'measure': 'Assessment of PK parameter: Area under curve from 0 to 24 hours (AUCtau)', 'timeFrame': 'On Day 1 and Day 8', 'description': 'Sotagliflozin and Sotagliflozin-O-glucuronide: Area under curve from 0 to 24 hours (AUCtau) of sotagliflozin'}, {'measure': 'Assessment of PK parameter: Area under the concentration-time curve (AUC)', 'timeFrame': 'From Day 8 to Day 13', 'description': 'Sotagliflozin and Sotagliflozin-O-glucuronide: Area under the concentration-time curve from 0 to infinity'}, {'measure': 'Assessment of PD parameter: urinary glucose excretion (UGE)', 'timeFrame': 'On Day 1 and Day 8', 'description': 'Total 24-hour urinary glucose excretion (UGE) after dose with sotagliflozin'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\nTo assess the safety and tolerability of sotagliflozin after a multiple oral dose administration in Chinese healthy subjects.\n\nSecondary Objectives:\n\n* To assess the pharmacokinetic (PK) parameters of sotagliflozin after a multiple oral dose administration in Chinese healthy subjects.\n* To assess the pharmacodynamics (PD) parameters of absolute urinary glucose excretion after a multiple oral dose administration in Chinese healthy subjects.', 'detailedDescription': 'The study duration per subject will be up to 41 days and will consist of a screening period of up to 28 days, a dosing period of 8 days, and a follow up visit 5 days after last dosing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion criteria :\n\n* Male or female subjects, between 18 and 45 years of age, inclusive.\n* Body weight between 50.0 and 95.0 kg, inclusive, for male or female subjects; body mass index between 18.5 and 27.9 kg/m2, inclusive.\n* Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination), vital signs, electrocardiogram, and clinical laboratory parameters.\n\nExclusion criteria:\n\n* Any history or presence of clinically relevant illness at screening, which could interfere with the objectives of the study or the safety of the subject's participation.\n* Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting only: more than twice a month).\n* Blood donation any volume, within 2 months before inclusion.\n* Symptomatic postural hypotension.\n* Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician.\n* History or presence of drug or alcohol abuse.\n* Smoking more than 5 cigarettes or equivalent per day, unable to stop smoking during the study.\n* If female, pregnancy, breast-feeding.\n* Any medication (including St John's Wort) within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication; any vaccination within the last 28 days and any biologics (antibody or its derivatives) given within 4 months before inclusion.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT03909451', 'briefTitle': 'Sotagliflozin Multiple-dose Study in Healthy Chinese Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Phase 1, Randomized, Double-blind, Placebo-controlled, Ascending Multiple-dose Study to Determine the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Orally Administered Sotagliflozin in Healthy Chinese Subjects', 'orgStudyIdInfo': {'id': 'TDR15349'}, 'secondaryIdInfos': [{'id': 'U1111-1199-6171', 'type': 'OTHER', 'domain': 'UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose 1', 'description': 'Sotagliflozin dose 1, once daily for 8 days', 'interventionNames': ['Drug: Sotagliflozin (SAR439954)']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 2', 'description': 'Sotagliflozin dose 2, once daily for 8 days', 'interventionNames': ['Drug: Sotagliflozin (SAR439954)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo, once daily for 8 days', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Sotagliflozin (SAR439954)', 'type': 'DRUG', 'description': 'Pharmaceutical form: tablet\n\nRoute of administration: oral', 'armGroupLabels': ['Dose 1', 'Dose 2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Pharmaceutical form: tablet\n\nRoute of administration: oral', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'country': 'China', 'facility': 'Investigational Site Number 1560001', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Clinical Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}