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Sotagliflozin Bioequivalence Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03211195
Recruitment Status : Completed
First Posted : July 7, 2017
Last Update Posted : August 25, 2017
Sponsor:
Information provided by (Responsible Party):
Sanofi

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Sotagliflozin (SAR439954) Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 29, 2017
Actual Primary Completion Date : August 22, 2017
Actual Study Completion Date : August 22, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sotagliflozin - Commerical
Healthy volunteers will be administered a single dose Sotagliflozin (SAR439954) tablet (Commercial formulation) by mouth under fasted conditions
Drug: Sotagliflozin (SAR439954)

Pharmaceutical form: tablet

Route of administration: oral


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

Pharmaceutical form: tablet

Route of administration: oral





Primary Outcome Measures :
  1. Assessment of PK (pharmacokinetic) parameter: Cmax [ Time Frame: From 0 to 120 hours after SAR439954 intake ]
    Sotagliflozin: Maximum plasma concentration (Cmax)

  2. Assessment of PK parameter: AUClast [ Time Frame: From 0 to 120 hours after SAR439954 intake ]
    Sotagliflozin: Area under the concentration-time curve from 0 to last quantifiable concentration (AUClast)

  3. Assessment of PK parameter: AUC [ Time Frame: From 0 to 120 hours after SAR439954 intake ]
    Sotagliflozin: Area under the concentration-time curve from 0 to infinity


Secondary Outcome Measures :
  1. Assessment of PK parameter: Tmax [ Time Frame: From 0 to 120 hours after SAR439954 intake ]
    Sotagliflozin: Time to reach maximum plasma concentration (Tmax)

  2. Assessment of PK parameter: t1/2 [ Time Frame: From 0 to 120 hours after SAR439954 intake ]
    Sotagliflozin: Terminal elimination half life (T1/2)

  3. Assessment of PK parameter: Vz/F [ Time Frame: From 0 to 120 hours after SAR439954 intake ]
    Sotagliflozin: Apparent volume of distribution during terminal phase after non-intravenous administration Vz/F

  4. Assessment of PK parameter: CL/F [ Time Frame: From 0 to 120 hours after SAR439954 intake ]
    Sotagliflozin: Apparent total body clearance of a drug from the plasma (CL/F)

  5. Assessment of PK parameter: Cmax [ Time Frame: From 0 to 120 hours after SAR439954 intake ]
    Sotagliflozin 3-O-glucuronide: Maximum plasma concentration (Cmax)

  6. Assessment of PK parameter: AUC [ Time Frame: From 0 to 120 hours after SAR439954 intake ]
    Sotagliflozin 3-O-glucuronide: Area under the concentration-time curve from 0 to infinity

  7. Assessment of PK parameter: AUClast [ Time Frame: 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)

  8. Assessment of PK parameter: Tmax [ Time Frame: From 0 to 120 hours after SAR439954 intake ]
    Sotagliflozin 3-O-glucuronide: Time to reach maximum plasma concentration (Cmax)

  9. Assessment of PK parameter: t1/2 [ Time Frame: From 0 to 120 hours after SAR439954 intake ]
    Sotagliflozin 3-O-glucuronide: Terminal elimination half life (T1/2)

  10. Treatment emergent adverse events (TEAE) [ Time Frame: From 0 to 144 hours after SAR439954 intake ]
    Number treatment emergent adverse events



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03211195


Locations
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United States, Florida
Investigational Site Number 840001
Miami, Florida, United States, 33014
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT03211195    
Other Study ID Numbers: BEQ15271
U1111-1197-7610 ( Other Identifier: UTN )
First Posted: July 7, 2017    Key Record Dates
Last Update Posted: August 25, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data (IPD) and supporting clinical documents are available for request at clinicalstudydatarequest.com. While making information available Sanofi continues to protect the privacy of the participants in clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs