NCT03909451

Sotagliflozin Multiple-dose Study in Healthy Chinese Subjects

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Sotagliflozin (SAR439954)	Pharmaceutical form: tablet Route of administration: oral
DRUG	Placebo	Pharmaceutical form: tablet Route of administration: oral

Timeline

• Start date: 2019-04-28
• Primary completion: 2019-08-19
• Completion: 2019-08-19
• First posted: 2019-04-10
• Last updated: 2022-04-25

Locations

1 site across 1 country: China