Sotagliflozin Multiple-dose Study in Healthy Chinese Subjects

Sanofi

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus

Treatments: Drug: Placebo; Drug: Sotagliflozin (SAR439954)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03909451

TDR15349

U1111-1199-6171 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

---

24 participants in 3 patient groups, including a placebo group

Dose 1

Experimental group

Description:

Sotagliflozin dose 1, once daily for 8 days

Treatment:

Drug: Sotagliflozin (SAR439954)

Dose 2

Experimental group

Description:

Sotagliflozin dose 2, once daily for 8 days

Treatment:

Drug: Sotagliflozin (SAR439954)

Placebo

Placebo Comparator group

Description:

Placebo, once daily for 8 days

Treatment:

Drug: Placebo