Effect of Rifampicin on the Pharmacokinetics and Pharmacodynamics of Sotagliflozin

NCT03063580 | Completed Phase 1 FDA Drug

• 2 other identifiers: INT14936U1111-1186-2980
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective: To evaluate the effects of rifampicin on the pharmacokinetics (PK) of sotagliflozin and its metabolite in healthy male and female subjects. Secondary Objectives:

• To assess total 24-hour urinary glucose excretion (UGE) after a dose of sotagliflozin 400 mg, alone and with rifampicin, in healthy male and female subjects.
• To assess the safety and tolerability of single dose sotagliflozin with and without rifampicin in healthy male and female subjects.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (3)

• Maximum plasma concentration (Cmax)

  Up to 96 hours post SAR439954 dosing

• Area under the concentration-time curve from 0 to the last quantifiable concentration (AUC0-tlast)

  Up to 96 hours post SAR439954 dosing

• Area under the concentration-time curve from 0 to infinity (AUC0 ∞)

  Up to 96 hours post SAR439954 dosing

Secondary Outcomes (1)

• Total 24-hour UGE (urinary glucose excretion)

  Up to 24 hours after SAR439954 intake

Study Arms (1)

SAR439954 with or without rifampicin

EXPERIMENTAL

Period 1: single oral dose of 400 mg sotagliflozinon Day 1 morning Period 2: once-daily oral doses of 600 mg rifampicin from Days 1 to 10 and a single oral dose of 400 mg sotagliflozin

Drug: Sotagliflozin (SAR439954); Drug: Rifampicin

Interventions

Sotagliflozin (SAR439954) DRUG

Pharmaceutical form: tablets Route of administration: oral

SAR439954 with or without rifampicin

Rifampicin DRUG

Pharmaceutical form: capsules Route of administration: oral

SAR439954 with or without rifampicin

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female subjects, between 18 and 55 years of age, inclusive.
• Body weight between 50.0 and 100.0 kg, inclusive, if male, and between 40.0 and 90.0 kg, inclusive, if female.
• Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
• Normal vital signs, ECG, and laboratory parameters. Total bilirubin out of normal range can be acceptable if total bilirubin should not exceed 1.5 the upper limit with normal conjugated bilirubin values (unless the subject has documented Gilbert syndrome).
• Female subject must use a double contraception method including a highly effective method of birth control, except if she has undergone sterilization at least 3 months earlier or is postmenopausal.
• Having given written informed consent prior to undertaking any study-related procedure.
• Covered by a health insurance system where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research.
• Not under any administrative or legal supervision.

You may not qualify if:

• Any history or presence of clinically relevant disease 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 (more than twice a month).
• Symptomatic postural hypotension, irrespective of the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease in systolic blood pressure ≥20 mmHg within 3 minutes when changing from supine to standing position.
• History or presence of drug or alcohol abuse.
• Smoking more than 5 cigarettes or equivalent per day, unable to stop smoking during the study.
• Excessive consumption of beverages containing xanthine bases (more than 4 cups or glasses per day).
• If female, pregnancy (defined as positive β-HCG (human chorionic gonadotropin) blood test if applicable), breast-feeding.
• Any subject who cannot be contacted in case of emergency.
• Any subject who is the Investigator or any sub-investigator, research assistant, pharmacist, study coordinator, or other staff thereof, directly involved in conducting the study.
• 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 250001

Gières, 38610, France

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; Rifampin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2017
• First Posted: February 24, 2017
• Study Start: February 27, 2017
• Primary Completion: May 12, 2017
• Study Completion: May 12, 2017
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share

Locations

FR (1)