Sotagliflozin Bioequivalence Study

NCT03211195 | Completed Phase 1 FDA Drug

• 2 other identifiers: BEQ15271U1111-1197-7610
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (3)

• Assessment of PK (pharmacokinetic) parameter: Cmax

  Sotagliflozin: Maximum plasma concentration (Cmax)

  From 0 to 120 hours after SAR439954 intake

• Assessment of PK parameter: AUClast

  Sotagliflozin: Area under the concentration-time curve from 0 to last quantifiable concentration (AUClast)

  From 0 to 120 hours after SAR439954 intake

• Assessment of PK parameter: AUC

  Sotagliflozin: Area under the concentration-time curve from 0 to infinity

  From 0 to 120 hours after SAR439954 intake

Secondary Outcomes (10)

• Assessment of PK parameter: Tmax

  From 0 to 120 hours after SAR439954 intake

• Assessment of PK parameter: t1/2

  From 0 to 120 hours after SAR439954 intake

• Assessment of PK parameter: Vz/F

  From 0 to 120 hours after SAR439954 intake

• Assessment of PK parameter: CL/F

  From 0 to 120 hours after SAR439954 intake

• Assessment of PK parameter: Cmax

  From 0 to 120 hours after SAR439954 intake

Study Arms (2)

Sotagliflozin - Commerical

EXPERIMENTAL

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

Drug: Sotagliflozin (SAR439954)

Sotagliflozin -Development

ACTIVE COMPARATOR

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

Drug: Sotagliflozin (SAR439954)

Interventions

Sotagliflozin (SAR439954) DRUG

Pharmaceutical form: tablet Route of administration: oral

Sotagliflozin - Commerical; Sotagliflozin -Development

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Investigational Site Number 840001

Miami, Florida, 33014, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2017
• First Posted: July 7, 2017
• Study Start: June 29, 2017
• Primary Completion: August 22, 2017
• Study Completion: August 22, 2017
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)