Sotagliflozin Multiple-dose Study in Healthy Chinese Subjects

Phase 1

Completed

• Conditions: Diabetes Mellitus
• Interventions: Drug: Sotagliflozin (SAR439954); Drug: Placebo

• Registration Number: NCT03909451
• Lead Sponsor: Sanofi

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.

Study Timeline

• Study First Submitted: 2019-04-08
• Study First Submitted QC: 2019-04-08
• Study First Posted: 2019-04-10
• Study Start: 2019-04-28
• Primary Completion: 2019-08-19
• Study Completion: 2019-08-19
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-22
• Last Update Posted: 2022-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Dose 1	Sotagliflozin (SAR439954)	Sotagliflozin dose 1, once daily for 8 days
Placebo	Placebo	Placebo, once daily for 8 days
Dose 2	Sotagliflozin (SAR439954)	Sotagliflozin dose 2, once daily for 8 days

Primary Outcome Measures

Name	Time	Method
Adverse events (AEs)	Up to 41 days	Proportion of patients who experienced adverse events/treatment-emergent AEs (TEAE)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Investigational Site Number 1560001; 🇨🇳 Beijing, China