A Study to Evaluate the Effect of Food on the Pharmacokinetics of Sotagliflozin and to Explore the Relative Bioavailability in Healthy Subjects

A Phase 1, Randomized, Single-center, Open-label, Three-sequence, Three-period, Three-treatment Crossover Study to Evaluate the Effect of Food on the Single-dose Pharmacokinetics of Sotagliflozin and to Explore the Relative Bioavailability of Sotagliflozin Oral Tablet to Oral Solution in Healthy Male and Female Subjects

Primary Objective:

To evaluate the effect of food on the single-dose pharmacokinetics of sotagliflozin relative to a fasted state in healthy adult male and female subjects.

Secondary Objectives:

• To evaluate the effect of food on the single-dose pharmacokinetics of the main metabolite (sotagliflozin 3-O-glucuronide) relative to a fasted state in healthy adult male and female subjects.
• To investigate the relative bioavailability of sotagliflozin tablet to oral solution under fasting conditions
• To evaluate safety and tolerability of single-dose sotagliflozin under fed and fasted conditions in healthy adult male and female subjects.

The study duration per subject will be 26 to 83 days and will consist of a screening period of 2-28 days, a treatment period of 6 days each for Periods 1, 2 and 3, a washout between treatment periods of 1-14 days, and follow up visit 10-15 days after the last Investigational Medicinal Product administration in period 3.

Inclusion criteria :

• Healthy male and female subjects, between 18 and 55 years of age, inclusive, at the time of screening.
• 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), vital signs, ECG, and clinical laboratory parameters.

Exclusion criteria:

• 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.
• Frequent headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month).
• Blood donation any volume, within 2 months before inclusion.
• Symptomatic postural hypotension.
• Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician.
• History or presence of drug or alcohol abuse.
• Smoking more than 5 cigarettes or equivalent per day, unable to stop smoking during the study.
• If female, pregnancy, 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.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.