Sotagliflozin Bioequivalence Study

NCT ID: NCT03211195

Last Updated: 2022-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-29
• Study Completion Date: 2017-08-22

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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sotagliflozin - Commerical

Healthy volunteers will be administered a single dose Sotagliflozin (SAR439954) tablet (Commercial formulation) by mouth under fasted conditions

Group Type: EXPERIMENTAL

Sotagliflozin (SAR439954)

Intervention Type: DRUG

Pharmaceutical form: tablet

Route of administration: oral

Sotagliflozin -Development

Healthy volunteers will be administered a single dose Sotagliflozin (SAR439954) tablet (Development formulation) by mouth under fasted conditions - Type: Active Comparator

Group Type: ACTIVE_COMPARATOR

Sotagliflozin (SAR439954)

Intervention Type: DRUG

Pharmaceutical form: tablet

Route of administration: oral

Interventions

Sotagliflozin (SAR439954)

Pharmaceutical form: tablet

Route of administration: oral

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number 840001

Miami, Florida, United States

Countries

United States

Other Identifiers

U1111-1197-7610

Identifier Type: OTHER

Identifier Source: secondary_id

BEQ15271

Identifier Type: -

Identifier Source: org_study_id