A Drug to Drug Interaction Study of Sotagliflozin With Midazolam and Metoprolol

The total study duration per subject is up to 58 days.

Inclusion criteria :

- Male or female healthy 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/m^2, inclusive.

- Normal vital signs, electrocardiogram (ECG), and laboratory parameters

- Female subjects must use a double contraception method during the study, except if
she has undergone sterilization at least 3 months earlier or is postmenopausal. The
accepted double contraception methods include the use of one of the following
contraceptive options: (1) condom; (2) diaphragm or cervical/vault cap; (3)
spermicide in addition to the use of one of the following: a) Intrauterine device
(IUD); b) Vasectomized partner; c) Sexual abstinence. Hormonal contraception is NOT
acceptable in this study.

Exclusion criteria:

Any history or presence of clinically relevant cardiovascular, pulmonary,
gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular,
articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute
illness.

Frequent headaches and/or migraine, recurrent nausea and/or vomiting.

- Blood donation, any volume, within 2 months before inclusion.

- Symptomatic postural hypotension.

- Presence or history of drug hypersensitivity, allergic disease or asthma diagnosed
and treated by a physician.

- History or presence of drug or alcohol abuse.

- If female, pregnancy or breast-feeding.

- 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. Any oral contraceptives during the screening
period or for at least 15 days prior to the first dose of Period 1; any injectable
contraceptives or hormonal intrauterine devices within 12 months prior to the first
dose of Period 1; or topical controlled delivery contraceptives (patch) for 3 months
prior to the first dose of Period 1.

- Any contra-indications to metoprolol, according to the applicable labeling.

- Any contra-indications to midazolam, according to the applicable labeling.

- Any consumption of citrus (grapefruit, orange, etc.) or their juices within 5 days
before inclusion.

- 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.