Type 2 Diabetes Mellitus
Conditions
Brief summary
Primary Objective: To determine the bioequivalence of a single dose of the commercial tablet of sotagliflozin (test) compared to the development tablet of sotagliflozin (reference) under fasting conditions in healthy male and female subjects. Secondary Objectives: * To evaluate the single-dose pharmacokinetics of sotagliflozin and its main metabolite sotagliflozin 3-O-glucuronide following administration of a single sotagliflozin (test) tablet or a single sotagliflozin (reference) table in healthy male and female subjects under fasting conditions. * To evaluate safety and tolerability of a single dose sotagliflozin (test) tablet compared to a single sotagliflozin (reference) tablet administered under fasted conditions in healthy male and female subjects.
Detailed description
The study duration per subject will be 36-99 days and will consist of a screening period of 2 to 21 days, a study period of 7 days for each of four periods, and a washout of 8-21 days between each dose administration, and a final follow up visit 10-15 days after final dose administration.
Interventions
Pharmaceutical form: tablet Route of administration: oral
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
: * Healthy male and female subjects 18-55 years old inclusive, male or female. * Certified as healthy by comprehensive clinical assessment (detailed medical history and complete physical examination). * 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 (BMI) of 18.0 to 30.0 kg/m2 inclusive. * Normal vital signs, ECG and laboratory parameters. * Female subjects must use a double contraception method including a highly effective method of contraception except if she has undergone sterilization at least 3 months earlier or is post-menopausal. Hormonal contraception is permitted in this study. * Having given written informed consent prior to undertaking of study procedure. * Covered by a health insurance system where applicable, and/or in compliance with the recommendation of the national laws in force relating to biomedical research. * Not under any administrative or legal supervision. * Male subjects, whose partners are of childbearing potential (including lactating women) must accept to use, during sexual intercourse, a double contraception method from the inclusion up to 3 months after the last dosing. * Male subjects, who partners are pregnant, must use during sexual intercourse a condom from inclusion to three months after the last dosing. * Male subject has agreed not to donate sperm from the time of inclusion up to 3 months after the last dosing.
Exclusion criteria
* Any history or presence of clinically relevant disease at screening which could interfere with the objectives of the study or the safety fo the subject's participation. * History of renal disease, or significantly abnormal kidney function test (glomerular filtration rate \[GFR\]\<90 mg/min as calculated using the Cockcroft-Gault equation) at screening. * Frequent headaches and/or migraines, recurrent nausea and/or vomiting. * Blood donation of a pint or more within 2 months before inclusion. * Symptomatic, postural hypotension, irrespective of the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease in systolic blood pressure of 20 mmHg or more within 3 minutes when changing from supine to standing position. * Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician. * Any history of presence of deep vein thrombosis or pulmonary embolism or a recurrent or frequent history of deep vein thrombosis in first degree relatives (parents, siblings, or children). * Any presence or history of urinary tract infection or genital mycotic infection in the last 4 weeks before screening. * History or presence of drug or alcohol abuse. * Smoking more than 5 cigarettes or equivalent per day, unable to stop smoking during the study. * Excessive consumption of beverages containing xanthine bases (more than 4 cups or glasses per day). * If female, pregnancy (defined as positive beta-HCG) blood test if applicable) breast-feeding. * Any medication (including St John's Wort) within 14 days before inclusion or within 5 time 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 or within 5 terminal elimination half-life of the biologic. * Any subject in the exclusion period of a previous study according to applicable regulations. * Any subject who cannot be contracted in the case of an emergency. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of PK (pharmacokinetic) parameter: Cmax | From 0 to 120 hours after SAR439954 intake | Sotagliflozin: Maximum plasma concentration (Cmax) |
| Assessment of PK parameter: AUClast | From 0 to 120 hours after SAR439954 intake | Sotagliflozin: Area under the concentration-time curve from 0 to last quantifiable concentration (AUClast) |
| Assessment of PK parameter: AUC | From 0 to 120 hours after SAR439954 intake | Sotagliflozin: Area under the concentration-time curve from 0 to infinity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of PK parameter: CL/F | From 0 to 120 hours after SAR439954 intake | Sotagliflozin: Apparent total body clearance of a drug from the plasma (CL/F) |
| Assessment of PK parameter: Cmax | From 0 to 120 hours after SAR439954 intake | Sotagliflozin 3-O-glucuronide: Maximum plasma concentration (Cmax) |
| Assessment of PK parameter: Tmax | From 0 to 120 hours after SAR439954 intake | Sotagliflozin: Time to reach maximum plasma concentration (Tmax) |
| Assessment of PK parameter: AUClast | From 0 to 120 hours after SAR439954 intake | Sotagliflozin 3-O-glucuronide: Area under the concentration-time curve from 0 to last quantifiable concentration (AUClast) |
| Treatment emergent adverse events (TEAE) | From 0 to 144 hours after SAR439954 intake | Number treatment emergent adverse events |
| Assessment of PK parameter: AUC | From 0 to 120 hours after SAR439954 intake | Sotagliflozin 3-O-glucuronide: Area under the concentration-time curve from 0 to infinity |
| Assessment of PK parameter: t1/2 | From 0 to 120 hours after SAR439954 intake | Sotagliflozin: Terminal elimination half life (T1/2) |
| Assessment of PK parameter: Vz/F | From 0 to 120 hours after SAR439954 intake | Sotagliflozin: Apparent volume of distribution during terminal phase after non-intravenous administration Vz/F |
Countries
United States
Outcome results
None listed