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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
Pharmaceutical form: tablet Route of administration: oral
Pharmaceutical form: tablet Route of administration: oral
Investigational Site Number 1560001
Beijing, China
Adverse events (AEs)
Proportion of patients who experienced adverse events/treatment-emergent AEs (TEAE)
Time frame: Up to 41 days
Assessment of PK parameter: Maximum plasma concentration (Cmax)
Sotagliflozin and Sotagliflozin-O-glucuronide: Maximum plasma concentration (Cmax)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: On Day 1 and Day 8
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