A Bioequivalence Study Testing Two Formulations of Sotagliflozin in Healthy Male and Female Subjects Under Fasted Conditions

NCT03776227 | Completed Phase 1 FDA Drug

• 2 other identifiers: BEQ14993U1111-1205-3319
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective: To determine the bioequivalence of a single dose of one tablet of sotagliflozin (test) compared to two tablets of sotagliflozin (reference) under fasting conditions in healthy male and female subjects Secondary Objectives:

• To evaluate the single-dose pharmacokinetics of sotagliflozin following administration of one tablet sotagliflozin (test) compared to two tablets of sotagliflozin (reference) in healthy male and female subjects under fasting conditions
• To evaluate safety and tolerability of one tablet sotagliflozin (test) compared to two tablets of sotagliflozin (reference) administered under fasted conditions in healthy male and female subjects

Conditions

Type 2 Diabetes Mellitus; Healthy Subjects

Outcome Measures

Primary Outcomes (2)

• Cmax

  Maximum plasma concentration observed

  Day 1 of each period

• AUC 0-72h (area under the curve)

  Truncated AUC 0-72h

  Day 1 to Day 3 of each period

Secondary Outcomes (8)

• Time to reach Cmax (tmax)

  Day 1 of each period

• Terminal half-life (t1/2z)

  Day 1 to Day 7 of each period

• Area under the plasma concentration versus time curve (AUClast)

  Day 1 to Day 7 of each period

• Adverse events

  Day 1 to Day 7 of each period

• Electrocardiograms (ECGs)

  Day 1 to Day 7 of each period

Study Arms (2)

Sotagliflozin Test

EXPERIMENTAL

One tablet of sotagliflozin administered orally under fasting conditions

Drug: sotagliflozin (SAR439954)

Sotagliflozin Reference

ACTIVE COMPARATOR

Two tablets of sotagliflozin administered orally under fasting conditions

Drug: sotagliflozin (SAR439954)

Interventions

sotagliflozin (SAR439954) DRUG

Pharmaceutical form: tablet Route of administration: oral

Sotagliflozin Reference; Sotagliflozin Test

Eligibility Criteria

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

You may qualify if:

• Healthy 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.
• Body mass index between 18.0 and 30.0 kg/m2, inclusive.
• Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
• Normal vital signs after 10 minutes resting in supine position and after 3 minutes in standing position:
• mmHg \< systolic blood pressure (SBP) \<140 mmHg
• mmHg \< diastolic blood pressure (DBP) \<90 mmHg
• bpm \< heart rate (HR) \<100 bpm
• Standard 12-lead electrocardiogram (ECG) parameters after 10 minutes resting in supine position in the following ranges; 120 ms\<PR\<220 ms, QRS\<120 ms, QTc≤430 ms if male, ≤450 ms if female and normal ECG tracing unless the Investigator considers an ECG tracing abnormality to be not clinically relevant.
• Laboratory parameters within the normal range, unless the Investigator considers an abnormality to be clinically irrelevant for healthy subjects; however serum creatinine, alkaline phosphatase, hepatic enzymes (aspartate aminotransferase, alanine aminotransferase), and total bilirubin (unless the subject has documented Gilbert syndrome) should not exceed the upper laboratory norm.
• 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. The accepted double contraception methods include the use of 2 of the following 3 contraceptive options: (1) intrauterine device; (2) hormonal contraception; (3) condom or diaphragm or cervical/vault cap, in addition to spermicide. Menopause is defined as being amenorrheic for at least 2 years with plasma follicule-stimulating hormone (FSH) level \>30 UI/L. Hormonal contraception is acceptable in this study (contraceptive guidance will be described in the study protocol).
• Having given written informed consent prior to undertaking any study-related procedure.
• Not under any administrative or legal supervision.

You may not qualify if:

• Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal (especially pancreatitis), hepatic (especially biliary disease, including cholecystectomy), renal, metabolic, hematological, neurological, musculoskeletal, articular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness.
• History of renal disease, or significantly abnormal kidney function test (glomerular filtration rate (GFR) \<90 mL/min as calculated using the Cockcroft-Gault equation (7) at screening.
• 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.
• Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician.
• History or presence of drug or alcohol abuse (alcohol consumption more than 40 g per day on a regular basis).
• Smoking more than 5 cigarettes or equivalent per day and/or 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 human chorionic gonadotropin (β-HCG blood test), breast-feeding.
• Any subject who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development.
• 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.
• Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen, anti hepatitis C virus antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti HIV1 and anti HIV2 Ab).
• Positive result on urine drug screen (amphetamines/methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates).
• Positive alcohol test.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Investigational Site Number 8400001

Miami, Florida, 33014, United States

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

Condition Hierarchy (Ancestors)

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

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: December 12, 2018
• First Posted: December 14, 2018
• Study Start: January 25, 2019
• Primary Completion: April 22, 2019
• Study Completion: April 22, 2019
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)