Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-01-27 @ 7:04 AM
Study NCT ID:
NCT03387657
Status:
COMPLETED
Last Update Posted:
2022-04-25
First Post:
2017-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Drug to Drug Interaction Study of Sotagliflozin With Hydrochlorothiazide
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': 'D006852', 'term': 'Hydrochlorothiazide'}], 'ancestors': [{'id': 'D002740', 'term': 'Chlorothiazide'}, {'id': 'D001581', 'term': 'Benzothiadiazines'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D049971', 'term': 'Thiazides'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2018-03-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-21', 'studyFirstSubmitDate': '2017-12-20', 'studyFirstSubmitQcDate': '2017-12-22', 'lastUpdatePostDateStruct': {'date': '2022-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of PK parameter: AUCtau', 'timeFrame': 'Period 1, days 2 to 6', 'description': 'Sotagliflozin without HCTZ: AUC to the end of the dosing period (AUCtau)'}, {'measure': 'Assessment of PK parameter: AUCtau', 'timeFrame': 'Period 2, days 6 to 10', 'description': 'Sotagliflozin with HCTZ: AUCtau'}], 'secondaryOutcomes': [{'measure': 'Assessment of PK parameter: AUCtau', 'timeFrame': 'Period 2, days 4 to 5', 'description': 'HCTZ without sotagliflozin: AUCtau'}, {'measure': 'Assessment of PK parameter: AUCtau', 'timeFrame': 'Period 2, days 9 to 10', 'description': 'HCTZ with sotagliflozin: AUCtau'}, {'measure': 'Assessment of PK parameter: AUCtau', 'timeFrame': 'Period 1, days 2 to 6', 'description': 'Sotagliflozin-3-O-glucuronide without HCTZ: AUCtau'}, {'measure': 'Assessment of PK parameter: AUCtau', 'timeFrame': 'Period 2, days 6 to 10', 'description': 'Sotagliflozin-3-O-glucuronide with HCTZ: AUCtau'}, {'measure': 'Assessment of PK parameter: Cmax', 'timeFrame': 'Period 2, days 4 to 5', 'description': 'HCTZ without sotagliflozin: Maximum plasma concentration (Cmax)'}, {'measure': 'Assessment of PK parameter: Cmax', 'timeFrame': 'Period 2, days 9 to 10', 'description': 'HCTZ with sotagliflozin: Cmax'}, {'measure': 'Assessment of PK parameter: Cmax', 'timeFrame': 'Period 1, days 2 to 6', 'description': 'Sotagliflozin-3-O-glucuronide without HCTZ: Cmax'}, {'measure': 'Assessment of PK parameter: Cmax', 'timeFrame': 'Period 2, days 6 to 10', 'description': 'Sotagliflozin-3-O-glucuronide with HCTZ: Cmax'}, {'measure': 'Assessment of PK parameter: tmax', 'timeFrame': 'Period 2, days 4 to 5', 'description': 'HCTZ without sotagliflozin: Time to reach Cmax (tmax)'}, {'measure': 'Assessment of PK parameter: tmax', 'timeFrame': 'Period 2, days 9 to 10', 'description': 'HCTZ with sotagliflozin: tmax'}, {'measure': 'Assessment of PK parameter: tmax', 'timeFrame': 'Period 1, days 2 to 6', 'description': 'Sotagliflozin-3-O-glucuronide without HCTZ: tmax'}, {'measure': 'Assessment of PK parameter: tmax', 'timeFrame': 'Period 2, days 6 to 10', 'description': 'Sotagliflozin-3-O-glucuronide with HCTZ: tmax'}, {'measure': 'Assessment of PK parameter: Cmax', 'timeFrame': 'Period 1, days 2 to 6', 'description': 'Sotagliflozin without HCTZ: Cmax'}, {'measure': 'Assessment of PK parameter: Cmax', 'timeFrame': 'Period 2, days 6 to 10', 'description': 'Sotagliflozin with HCTZ: Cmax'}, {'measure': 'Assessment of PK parameter: tmax', 'timeFrame': 'Period 1, days 2 to 6', 'description': 'Sotagliflozin without HCTZ: tmax'}, {'measure': 'Assessment of PK parameter: tmax', 'timeFrame': 'Period 2, days 6 to 10', 'description': 'Sotagliflozin with HCTZ: tmax'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\nTo assess the effects of multiple-dose hydrochlorothiazide (HCTZ) on the steady-state pharmacokinetics (PK) of sotagliflozin.\n\nSecondary Objectives:\n\n* To assess the safety and tolerability of multiple-dose sotagliflozin with and without co-administration of multiple-dose HCTZ\n* To assess the effects of multiple-dose sotagliflozin on the steady-state PK of HCTZ\n* To assess the effects of multiple-dose HCTZ on the steady-state PK of sotagliflozin-3-O-glucuronide', 'detailedDescription': 'Duration of the study for each subject will be between 33 to 77 days, including screening up to 28 days, 5 days of treatment Period 1, washout period of 7-21 days, 9 days of treatment Period 2, and follow-up period of 10-14 days after last dose of the Investigational Medicinal Product (IMP) in Period 2.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion criteria :\n\n* Male or female subjects, between 18 and 55 years of age, inclusive.\n* Body weight between 50.0 and 100.0 kg, inclusive, if male, and between 40.0 and 90.0 kg, inclusive, if female, body mass index between 18.0 and 30.0 kg/m2, inclusive.\n* Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).\n* Normal vital signs, electrocardiogram, and laboratory parameters.\n* Female subject must use a double contraception method including a highly effective method of birth control, except if she has undergone sterilization at least 3 months earlier or is postmenopausal. The accepted double contraception methods include the use of 1 of the following contraceptive options: (1) intrauterine device; (2) condom or diaphragm or cervical/vault cap, in addition to spermicide. Menopause is defined as being amenorrheic for at least 2 years with plasma follicle stimulating hormone level \\>30 IU. Hormonal contraception is NOT acceptable in this study.\n* Male subject, whose partners are of childbearing potential (including lactating women), must accept to use, during sexual intercourse, a double contraception method according to the following algorithm: (condom) plus (spermicide or intra-uterine device or hormonal contraceptive) from the inclusion up to 4 months after the last dosing.\n* Male subject, whose partners are pregnant, must use, during sexual intercourse, a condom from the inclusion up to 4 months after the last dosing.\n* Male subject has agreed not to donate sperm from the inclusion up to 4 months after the last dosing.\n\nExclusion criteria:\n\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, with the exception of hormonal contraception or menopausal hormone replacement therapy; any vaccination within the last 28 days and any biologics (antibody or its derivatives) given within 4 months before inclusion.\n* Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen, anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab).\n* Positive result on urine drug screen or alcohol test.\n* Any contra-indications to hydrochlorothiazide, according to the applicable labeling.\n* Any history or presence of deep leg vein thrombosis or embolism or a recurrent or frequent appearance of deep leg vein thrombosis in first degree relatives (parents, siblings or children).\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT03387657', 'briefTitle': 'A Drug to Drug Interaction Study of Sotagliflozin With Hydrochlorothiazide', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Phase 1, Single-Center, Open-Label, Two-Period, Single-Sequence, Multiple Dosing Drug-Drug Interaction Study of Sotagliflozin and Hydrochlorothiazide in Healthy Male and Female Subjects', 'orgStudyIdInfo': {'id': 'INT14905'}, 'secondaryIdInfos': [{'id': 'U1111-1186-2718', 'type': 'OTHER', 'domain': 'UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sotagliflozin + Hydrochlorothiazide (HCTZ)', 'description': 'Sotagliflozin to be administered alone in Period 1. HCTZ to be given in Period 2 for 4 days followed immediately by HCTZ and sotagliflozin for 5 days.', 'interventionNames': ['Drug: Sotagliflozin (SAR439954)', 'Drug: Hydrochlorothiazide']}], 'interventions': [{'name': 'Sotagliflozin (SAR439954)', 'type': 'DRUG', 'description': 'Pharmaceutical form: Tablet\n\nRoute of administration: Oral', 'armGroupLabels': ['Sotagliflozin + Hydrochlorothiazide (HCTZ)']}, {'name': 'Hydrochlorothiazide', 'type': 'DRUG', 'description': 'Pharmaceutical form: Tablet\n\nRoute of administration: Oral', 'armGroupLabels': ['Sotagliflozin + Hydrochlorothiazide (HCTZ)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75247', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site Number 8400001', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], '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'}}}}