Sotagliflozin Multiple-dose Study in Healthy Chinese Subjects

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03909451
• Other study ID #: TDR15349
• Secondary ID: U1111-1199-6171
• Status: Completed
• Phase: Phase 1
• Start date: April 28, 2019
• Est. completion date: August 19, 2019

Study information

• Verified date: April 2022
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 19, 2019
• Est. primary completion date: August 19, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Drug:
• Sotagliflozin (SAR439954)
Pharmaceutical form: tablet Route of administration: oral
• Placebo
Pharmaceutical form: tablet Route of administration: oral

Locations

Country	Name	City	State
China	Investigational Site Number 1560001	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events (AEs)	Proportion of patients who experienced adverse events/treatment-emergent AEs (TEAE)	Up to 41 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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