Study To Determine Bioavailability of Sotagliflozin in Healthy Male and Female Subjects

NCT03802487 | Completed Phase 1

• 3 other identifiers: PKM154022017-004937-94U1111-1200-2077
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective: To assess the absolute bioavailability of sotagliflozin via administration of an intravenous (IV) microdose of a 14C-sotagliflozin tracer on top of a single oral dose of unlabeled sotagliflozin without charcoal administration Secondary Objectives:

• To assess the PK of sotagliflozin and its main metabolite sotagliflozin-3-O-glucuronide (M19) after a single oral dose of sotagliflozin and an IV microdose of a 14C-sotagliflozin tracer without charcoal administration
• To assess the safety and tolerability of single doses of sotagliflozin when administered with and without charcoal

Conditions

Type 2 Diabetes Mellitus; Healthy Subjects

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic (PK) parameter: Absolute Bioavailability (F)

  Absolute Bioavailability (F) will be a composite endpoint and include Area under plasma concentration (AUC) dose normalized for intravenous (IV) 14C-IMP AUClast dose normalized for oral Investigational Medicinal Product (IMP)

  Baseline to Day 8 of period 1 (without charcoal)

Secondary Outcomes (25)

• Assessment of PK parameter: Area under the curve (AUC) for oral investigational medicinal product (IMP)

  Baseline to Day 8 of each period

• Assessment of PK parameter: AUC for IMP metabolite

  Baseline to Day 8 of each period

• Assessment of PK parameter: AUC for IV 14C-IMP

  Baseline to Day 8 of each period

• Assessment of PK parameter: AUC for 14C-IMP metabolite

  Baseline to Day 8 of each period

• Assessment of PK parameter: Area under curve versus time (AUClast) for oral IMP

  Baseline to Day 8 of each period

Study Arms (1)

Sotagliflozin

EXPERIMENTAL

One treatment period includes a single oral dose of sotagliflozin + IV microdose 14C-sotagliflozin tracer plus charcoal. The other treatment period includes a single oral dose of sotagliflozin + IV microdose 14C-sotagliflozin tracer without charcoal.

Drug: Sotagliflozin (SAR439954); Drug: 14C-microtracer; Drug: Charcoal

Interventions

Sotagliflozin (SAR439954) DRUG

Pharmaceutical form: Tablet Route of administration: Oral

Sotagliflozin

14C-microtracer DRUG

Pharmaceutical form: Solution for injection Route of administration: Intravenous

Sotagliflozin

Charcoal DRUG

Pharmaceutical form: Granules for suspension Route of administration: Oral

Sotagliflozin

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 120.0 kg, inclusive, if male, and between 40.0 and 100.0 kg, inclusive, if female, body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive. BMI between 30.0 and 32.0 is acceptable if investigator judges the subject to have a high muscle mass.
• Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
• Normal vital signs, ECG and laboratory parameters.

You may not qualify if:

• Any history or presence of clinically relevant abnormalities at screening which could interfere with the objectives of the study or the safety of the subject's participation.
• History or presence of drug or alcohol abuse.
• Smoking regularly more than 5 cigarettes or equivalent per week, unable to stop smoking during the study.
• Excessive consumption of beverages containing xanthine bases.
• If female, pregnancy (defined as positive β-Human Chorionic Gonadotropin blood test), breast-feeding.
• Any subject who cannot be contacted in case of emergency.
• Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen, anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies.
• Positive result on urine drug screen.
• Positive alcohol test.
• Participation in a study in which radioisotopes were administered or in which subject was exposed to any radiation other than normal background radiation within the 12 months before the screening visit.
• 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 8260001

Nottingham, NG11 6JS, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

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

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Carbon; Elements; Inorganic Chemicals

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: January 10, 2019
• First Posted: January 14, 2019
• Study Start: January 14, 2019
• Primary Completion: March 28, 2019
• Study Completion: March 28, 2019
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)