- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03310944
Comparison of Sotagliflozin Prototype Tablets With Reference Tablet in Healthy Subjects
An Open-label, Randomized, Single-dose, 4-period, 4-sequence Crossover Relative Bioavailability Study Comparing Sotagliflozin Prototypes Tablets With Reference Tablet in Healthy Subjects
Primary Objective:
To assess the relative bioavailability of sotagliflozin following single doses of 3 sotagliflozin prototype tablet formulations p1, p2 and p3 versus the reference tablet formulation in fasted conditions in healthy subjects.
Secondary Objectives:
- To assess the pharmacokinetic characteristics of sotagliflozin and its 3-O-glucuronide following single doses of 3 sotagliflozin prototype tablet formulations p1, p2 and p3 and of the reference formulation in fasted conditions in healthy subjects.
- To assess the clinical and laboratory safety of single oral doses of 3 sotagliflozin prototype tablet formulations p1, p2 and p3 and the reference tablet formulation in fasted conditions in healthy subjects.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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-
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Neuss, Germany, 41460
- Investigational Site Number 276001
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria :
- Healthy male or female subjects, between 18 and 55 years of age, inclusive.
- 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 between 18.0 and 32.0 kg/m², inclusive.
- Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
- Normal vital signs after 10 minutes resting in supine position:
- 95 mmHg <systolic blood pressure (SBP) <140 mmHg,
- 45 mmHg <diastolic blood pressure (DBP) <90 mmHg,
- 40 bpm <heart rate (HR) <100 bpm.
- Standard 12-lead electrocardiogram parameters after 10 minutes resting in supine position in the following ranges; 120 ms<PR<220 ms, QRS<120 ms, QTc≤430 ms if male and QTc≤450 ms if female with normal electrocardiogram (ECG) tracing unless the Investigator considers an ECG tracing abnormality to be not clinically relevant.
- Laboratory parameters within the normal range, unless the Investigator considers an abnormality to be clinically irrelevant for healthy subjects; however serum creatinine, alkaline phosphatase, hepatic enzymes (aspartate aminotransferase, alanine aminotransferase), and international normalized ratio (INR) should not exceed the upper laboratory norm. Activated partial thromboplastin time (aPTT) should not exceed normal control more than 10 seconds. Total bilirubin out of normal range can be acceptable if total bilirubin should not exceed 1.5 the upper limit with normal conjugated bilirubin values (unless the subject has documented Gilbert syndrome).
- Female subject must use a double contraception method including a highly effective method of birth control except if she has undergone sterilization at least 3 months earlier or is postmenopausal. The accepted double contraception methods include the use of 1 of the following contraceptive options: (1) intrauterine device; (2) condom or diaphragm or cervical/vault cap, in addition to spermicide. Menopause is defined as being amenorrheic for at least 2 years with plasma follicle-stimulating hormone (FSH) level >30 IU/L. Hormonal contraception is NOT acceptable in this study due to drug interaction.
- Having given written informed consent prior to undertaking any study-related procedure.
- Covered by a health insurance system where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research.
- Not under any administrative or legal supervision.
- Male subject, whose partners are of childbearing potential (including lactating women), must accept to use, during sexual intercourse, a double contraception method according to the following algorithm: (condom) plus (spermicide or intra-uterine device or hormonal contraceptive) from the inclusion up to 4 months after the last dosing.
- Male subject, whose partners are pregnant, must use, during sexual intercourse, a condom from the inclusion up to 4 months after the last dosing.
- Male subject has agreed not to donate sperm from the inclusion up to 4 months after the last dosing.
Exclusion criteria:
- Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness.
- History of renal disease, or significant abnormal kidney function test with glomerular filtration rate (GFR) <90 mL/min as calculated using the Cockcroft-Gault equation.
- Frequent headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month).
- Blood donation, any volume, within 2 months before inclusion.
- History or presence of drug or alcohol abuse (alcohol consumption more than 40 g per day on a regular basis).
- 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 β-HCG blood test if applicable), breast-feeding.
- Any medication (including St John's Wort) within 14 days before inclusion; any vaccination within the last 28 days and any biologics (antibody or its derivatives) given within 4 months before inclusion.
Any oral contraceptives during the screening period or for at least 15 days prior to inclusion; any injectable contraceptives or hormonal intrauterine devices within 12 months prior to inclusion; or topical controlled delivery contraceptives (patch) for 3 months prior to inclusion.
- Any subject in the exclusion period of a previous study according to applicable regulations.
- Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen, anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency Virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab).
- Positive result on urine drug screen (amphetamines/methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates).
- Positive alcohol test.
- Any consumption of citrus (grapefruit, orange, etc) or their juices within 5 days before inclusion.
- Any history or presence of deep leg vein thrombosis or embolism or a recurrent or frequent appearance of deep leg 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.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Sotagliflozin dose 1 (reference formulation)
Single oral dose on Day 1 of one of the four period in fasting condition
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Pharmaceutical form: tablets Route of administration: oral |
Experimental: Sotagliflozin dose 2 (prototype p1 formulation)
Single oral dose on Day 1 of one of the four period in fasting condition
|
Pharmaceutical form: tablets Route of administration: oral |
Experimental: Sotagliflozin dose 3 (prototype p2 formulation)
Single oral dose on Day 1 of one of the four period in fasting condition
|
Pharmaceutical form: tablets Route of administration: oral |
Experimental: Sotagliflozin dose 4 (prototype p3 formulation)
Single oral dose on Day 1 of one of the four period in fasting condition
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Pharmaceutical form: tablets Route of administration: oral |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of Pharmacokinetic (PK) Parameter: AUC
Time Frame: From 0 to 144 hours after IMP intake
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Sotagliflozin: Area under the concentration-time curve from 0 to infinity (AUC) for reference, p1, p2, and p3 formulations
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From 0 to 144 hours after IMP intake
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Assessment of PK Parameter: Area under the concentration-time curve from 0 to last quantifiable concentration (AUClast)
Time Frame: From 0 to 144 hours after IMP intake
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Sotagliflozin: Area under the concentration-time curve from 0 to last quantifiable concentration for reference, p1, p2, and p3 formulations
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From 0 to 144 hours after IMP intake
|
Assessment of PK Parameter: Maximum plasma concentration (Cmax)
Time Frame: From 0 to 144 hours after IMP intake
|
Sotagliflozin: Maximum plasma concentration (Cmax) for reference, p1, p2, and p3 formulations
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From 0 to 144 hours after IMP intake
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of PK Parameter: Tmax
Time Frame: From 0 to 144 hours after investigational medicinal product (IMP) intake
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Sotagliflozin: Time to reach maximum plasma concentration (Tmax)
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From 0 to 144 hours after investigational medicinal product (IMP) intake
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Assessment of PK Parameter: Time to reach AUClast (Tlast)
Time Frame: From 0 to 144 hours after IMP intake
|
Sotagliflozin: Time to reach AUClast
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From 0 to 144 hours after IMP intake
|
Assessment of PK Parameter: Terminal elimination half-life (t1/2)
Time Frame: From 0 to 144 hours after IMP intake
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Sotagliflozin: Terminal elimination half-life (t1/2)
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From 0 to 144 hours after IMP intake
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Assessment of PK Parameter: Tmax
Time Frame: From 0 to 144 hours after IMP intake
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Sotagliflozin 3-O-glucuronide: Tmax
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From 0 to 144 hours after IMP intake
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Assessment of PK Parameter: Tlast
Time Frame: From 0 to 144 hours after IMP intake
|
Sotagliflozin 3-O-glucuronide: Time to reach AUClast
|
From 0 to 144 hours after IMP intake
|
Assessment of PK Parameter: t1/2
Time Frame: From 0 to 144 hours after IMP intake
|
Sotagliflozin 3-O-glucuronide: t1/2
|
From 0 to 144 hours after IMP intake
|
Assessment of PK Parameter: Cmax
Time Frame: From 0 to 144 hours after IMP intake
|
Sotagliflozin 3-O-glucuronide: Cmax
|
From 0 to 144 hours after IMP intake
|
Assessment of PK Parameter: AUC
Time Frame: From 0 to 144 hours after IMP intake
|
Sotagliflozin 3-O-glucuronide: AUC
|
From 0 to 144 hours after IMP intake
|
Assessment of PK Parameter: AUClast
Time Frame: From 0 to 144 hours after IMP intake
|
Sotagliflozin 3-O-glucuronide: AUClast
|
From 0 to 144 hours after IMP intake
|
Adverse Events
Time Frame: Up to 75 days
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Number of patients with treatment emergent adverse events (serious and non-serious)
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Up to 75 days
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Immune System Diseases
- Autoimmune Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Diabetes Mellitus, Type 1
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Sodium-Glucose Transporter 2 Inhibitors
- (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
Other Study ID Numbers
- BDR14994
- 2017-002104-27
- U1111-1195-6292 (Other Identifier: UTN)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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