Clinical trial NCT03211195: Sotagliflozin Bioequivalence Study
Official title: Bioequivalence Study Comparing Sotagliflozin Tablet Commercial Formulation (Test) and Sotagliflozin Tablet Development Formulation (Reference) in Healthy Male and Female Subjects Under Fasted Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2017-07-07
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Assessment of PK (pharmacokinetic) parameter: Cmax
timeFrame: From 0 to 120 hours after SAR439954 intake
measure: Assessment of PK parameter: AUClast
timeFrame: From 0 to 120 hours after SAR439954 intake
measure: Assessment of PK parameter: AUC
timeFrame: From 0 to 120 hours after SAR439954 intake
Secondary outcomes:
measure: Assessment of PK parameter: Tmax
timeFrame: From 0 to 120 hours after SAR439954 intake
measure: Assessment of PK parameter: t1/2
timeFrame: From 0 to 120 hours after SAR439954 intake
measure: Assessment of PK parameter: Vz/F
timeFrame: From 0 to 120 hours after SAR439954 intake
measure: Assessment of PK parameter: CL/F
timeFrame: From 0 to 120 hours after SAR439954 intake
measure: Assessment of PK parameter: Cmax
timeFrame: From 0 to 120 hours after SAR439954 intake
measure: Assessment of PK parameter: AUC
timeFrame: From 0 to 120 hours after SAR439954 intake
measure: Assessment of PK parameter: AUClast
timeFrame: From 0 to 120 hours after SAR439954 intake
measure: Assessment of PK parameter: Tmax
timeFrame: From 0 to 120 hours after SAR439954 intake
measure: Assessment of PK parameter: t1/2
timeFrame: From 0 to 120 hours after SAR439954 intake
measure: Treatment emergent adverse events (TEAE)
timeFrame: From 0 to 144 hours after SAR439954 intake
Other outcomes:
Locations:
city: Miami
country: United States
facility: Investigational Site Number 840001
state: Florida
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: