Sotagliflozin Multiple-dose Study in Healthy Chinese Subjects

NCT03909451 | Completed Phase 1

• 2 other identifiers: TDR15349U1111-1199-6171
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Adverse events (AEs)

  Proportion of patients who experienced adverse events/treatment-emergent AEs (TEAE)

  Up to 41 days

Secondary Outcomes (4)

• Assessment of PK parameter: Maximum plasma concentration (Cmax)

  On Day 1 and from Day 8 to Day 13

• Assessment of PK parameter: Area under curve from 0 to 24 hours (AUCtau)

  On Day 1 and Day 8

• Assessment of PK parameter: Area under the concentration-time curve (AUC)

  From Day 8 to Day 13

• Assessment of PD parameter: urinary glucose excretion (UGE)

  On Day 1 and Day 8

Study Arms (3)

Dose 1

EXPERIMENTAL

Sotagliflozin dose 1, once daily for 8 days

Drug: Sotagliflozin (SAR439954)

Dose 2

EXPERIMENTAL

Sotagliflozin dose 2, once daily for 8 days

Drug: Sotagliflozin (SAR439954)

Placebo

PLACEBO COMPARATOR

Placebo, once daily for 8 days

Drug: Placebo

Interventions

Sotagliflozin (SAR439954) DRUG

Pharmaceutical form: tablet Route of administration: oral

Dose 1; Dose 2

Placebo DRUG

Pharmaceutical form: tablet Route of administration: oral

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Investigational Site Number 1560001

Beijing, 100730, China

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2019
• First Posted: April 10, 2019
• Study Start: April 28, 2019
• Primary Completion: August 19, 2019
• Study Completion: August 19, 2019
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)