Sotagliflozin Multiple-dose Study in Healthy Chinese Subjects

Study Overview
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Brief Summary
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Primary Objective: To assess the safety and tolerability of sotagliflozin after a multiple oral dose administration in Chinese healthy subjects. Secondary Objectives: To assess the pharmacokinetic (PK) parameters of sotagliflozin after a multiple oral dose administration in Chinese healthy subjects. To assess the pharmacodynamics (PD) parameters of absolute urinary glucose excretion after a multiple oral dose administration in Chinese healthy subjects.

Detailed Description
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The study duration per subject will be up to 41 days and will consist of a screening period of up to 28 days, a dosing period of 8 days, and a follow up visit 5 days after last dosing.

Official Title
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A Phase 1, Randomized, Double-blind, Placebo-controlled, Ascending Multiple-dose Study to Determine the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Orally Administered Sotagliflozin in Healthy Chinese Subjects

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Drug: Sotagliflozin (SAR439954)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria : Male or female subjects, between 18 and 45 years of age, inclusive. Body weight between 50.0 and 95.0 kg, inclusive, for male or female subjects; body mass index between 18.5 and 27.9 kg/m2, inclusive. Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination), vital signs, electrocardiogram, and clinical laboratory parameters. Exclusion criteria: Any history or presence of clinically relevant illness at screening, which could interfere with the objectives of the study or the safety of the subject's participation. Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting only: more than twice a month). Blood donation any volume, within 2 months before inclusion. Symptomatic postural hypotension. Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician. History or presence of drug or alcohol abuse. Smoking more than 5 cigarettes or equivalent per day, unable to stop smoking during the study. If female, pregnancy, breast-feeding. Any medication (including St John's Wort) within 14 days before inclusion or within 5 times 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. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose 1<br>Sotagliflozin dose 1, once daily for 8 days | Drug: Sotagliflozin (SAR439954)<br>* Pharmaceutical form: tablet Route of administration: oral<br>|
| Experimental: Dose 2<br>Sotagliflozin dose 2, once daily for 8 days | Drug: Sotagliflozin (SAR439954)<br>* Pharmaceutical form: tablet Route of administration: oral<br>|
| Placebo Comparator: Placebo<br>Placebo, once daily for 8 days | Drug: Placebo<br>* Pharmaceutical form: tablet Route of administration: oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events (AEs) | Proportion of patients who experienced adverse events/treatment-emergent AEs (TEAE) | Up to 41 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of PK parameter: Maximum plasma concentration (Cmax) | Sotagliflozin and Sotagliflozin-O-glucuronide: Maximum plasma concentration (Cmax) | On Day 1 and from Day 8 to Day 13 | 
| Assessment of PK parameter: Area under curve from 0 to 24 hours (AUCtau) | Sotagliflozin and Sotagliflozin-O-glucuronide: Area under curve from 0 to 24 hours (AUCtau) of sotagliflozin | On Day 1 and Day 8 | 
| Assessment of PK parameter: Area under the concentration-time curve (AUC) | Sotagliflozin and Sotagliflozin-O-glucuronide: Area under the concentration-time curve from 0 to infinity | From Day 8 to Day 13 | 
| Assessment of PD parameter: urinary glucose excretion (UGE) | Total 24-hour urinary glucose excretion (UGE) after dose with sotagliflozin | On Day 1 and Day 8 |