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

NCT ID: NCT03802487

Last Updated: 2022-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-14
• Study Completion Date: 2019-03-28

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

Detailed Description

Study duration per participant is up to 54 days including a screening period of up to 28 days, period 1 of 8 days, period 2 of 8 days, a washout period of at least 10 days, and a follow up period of 12-16 days.

The oral drug Sotagliflozin is metabolized by the liver and released in the bile juice into the intestine. Ingestion of charcoal a few hours after the drug administration circumvents the re-uptake of the drug from the intestine back into the blood circulation; instead, Sotagliflozin is eliminated with the feces. By comparison of Sotagliflozin drug administration with and without charcoal, the extent of this so-called enterohepatic circulation can be assessed.

Conditions

Type 2 Diabetes Mellitus; Healthy Subjects

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sotagliflozin

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.

Group Type: EXPERIMENTAL

Sotagliflozin (SAR439954)

Intervention Type: DRUG

Pharmaceutical form: Tablet

Route of administration: Oral

14C-microtracer

Intervention Type: DRUG

Pharmaceutical form: Solution for injection

Route of administration: Intravenous

Charcoal

Intervention Type: DRUG

Pharmaceutical form: Granules for suspension

Route of administration: Oral

Interventions

Sotagliflozin (SAR439954)

Pharmaceutical form: Tablet

Route of administration: Oral

Intervention Type: DRUG

14C-microtracer

Pharmaceutical form: Solution for injection

Route of administration: Intravenous

Intervention Type: DRUG

Charcoal

Pharmaceutical form: Granules for suspension

Route of administration: Oral

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• Blood donation (400 mL) within 3 months before inclusion.
• 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 medication (including St John's Wort) within 14 days before inclusion with the exception of menopausal hormone replacement therapy; any vaccination within last 28 days; any biologics given within last 4 months.
• Any subject in the exclusion period of a previous study.
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational site number 8260001

Nottingham, , United Kingdom

Countries

United Kingdom

Other Identifiers

2017-004937-94

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1200-2077

Identifier Type: OTHER

Identifier Source: secondary_id

PKM15402

Identifier Type: -

Identifier Source: org_study_id