Clinical trial NCT03909451: Sotagliflozin Multiple-dose Study in Healthy Chinese Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2019-04-10
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Adverse events (AEs)
timeFrame: Up to 41 days
Secondary outcomes:
measure: Assessment of PK parameter: Maximum plasma concentration (Cmax)
timeFrame: On Day 1 and from Day 8 to Day 13
measure: Assessment of PK parameter: Area under curve from 0 to 24 hours (AUCtau)
timeFrame: On Day 1 and Day 8
measure: Assessment of PK parameter: Area under the concentration-time curve (AUC)
timeFrame: From Day 8 to Day 13
measure: Assessment of PD parameter: urinary glucose excretion (UGE)
timeFrame: On Day 1 and Day 8
Other outcomes:
Locations:
city: Beijing
country: China
facility: Investigational Site Number 1560001
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: