a drug to drug interaction study of sotagliflozin with hydrochlorothiazide

Conditions: Type 2 Diabetes Mellitus

Summary: primary objective: to assess the effects of multiple-dose hydrochlorothiazide (hctz) on the steady-state pharmacokinetics (pk) of sotagliflozin. secondary objectives: * to assess the safety and tolerability of multiple-dose sotagliflozin with and without co-administration of multiple-dose hctz * to assess the effects of multiple-dose sotagliflozin on the steady-state pk of hctz * to assess the effects of multiple-dose hctz on the steady-state pk of sotagliflozin-3-o-glucuronide

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.

Eligibility criteria:
inclusion criteria : * male or female subjects, between 18 and 55 years of age, inclusive. * 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. * certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination). * normal vital signs, electrocardiogram, and laboratory parameters. * 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. * 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. * male subject, whose partners are pregnant, must use, during sexual intercourse, a condom from the inclusion up to 4 months after the last dosing. * male subject has agreed not to donate sperm from the inclusion up to 4 months after the last dosing. exclusion criteria: * 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. * 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). * positive result on urine drug screen or alcohol test. * any contra-indications to hydrochlorothiazide, according to the applicable labeling. * 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). the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.