Diabetes Mellitus
Conditions
Brief summary
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
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.
Interventions
Pharmaceutical form: tablet Route of administration: oral
DRUGPlacebo
Pharmaceutical form: tablet Route of administration: oral
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events (AEs) | Up to 41 days | Proportion of patients who experienced adverse events/treatment-emergent AEs (TEAE) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of PK parameter: Maximum plasma concentration (Cmax) | On Day 1 and from Day 8 to Day 13 | Sotagliflozin and Sotagliflozin-O-glucuronide: Maximum plasma concentration (Cmax) |
| Assessment of PK parameter: Area under curve from 0 to 24 hours (AUCtau) | On Day 1 and Day 8 | Sotagliflozin and Sotagliflozin-O-glucuronide: Area under curve from 0 to 24 hours (AUCtau) of sotagliflozin |
| Assessment of PK parameter: Area under the concentration-time curve (AUC) | From Day 8 to Day 13 | Sotagliflozin and Sotagliflozin-O-glucuronide: Area under the concentration-time curve from 0 to infinity |
| Assessment of PD parameter: urinary glucose excretion (UGE) | On Day 1 and Day 8 | Total 24-hour urinary glucose excretion (UGE) after dose with sotagliflozin |
Countries
China
Outcome results
None listed