A Study to Evaluate the Effect of Food on the Pharmacokinetics of Sotagliflozin and to Explore the Relative Bioavailability in Healthy Subjects

NCT03174548 | Completed Phase 1 FDA Drug

• 3 other identifiers: PKM150472016-004650-15U1111-1189-5094
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective: To evaluate the effect of food on the single-dose pharmacokinetics of sotagliflozin relative to a fasted state in healthy adult male and female subjects. Secondary Objectives:

• To evaluate the effect of food on the single-dose pharmacokinetics of the main metabolite (sotagliflozin 3-O-glucuronide) relative to a fasted state in healthy adult male and female subjects.
• To investigate the relative bioavailability of sotagliflozin tablet to oral solution under fasting conditions
• To evaluate safety and tolerability of single-dose sotagliflozin under fed and fasted conditions in healthy adult male and female subjects.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• Maximum plasma drug concentration (Cmax) of sotagliflozin

  From 0 to 120 hours after sotagliflozin intake

• Area under curve (AUC) of sotagliflozin

  From 0 to 120 hours after sotagliflozin intake

Secondary Outcomes (10)

• Sotagliflozin (tablet and oral solution):Apparent volume of distribution during terminal phase after non-intravenous administration (Vz/F)

  From 0 to 120 hours after sotagliflozin intake

• Sotagliflozin (tablet and oral solution): Time to reach maximum plasma concentration (tmax)

  From 0 to 120 hours after sotagliflozin intake

• Sotagliflozin (tablet and oral solution): Elimination half-life (t1/2z)

  From 0 to 120 hours after sotagliflozin intake

• Sotagliflozin-O-glucuronide (tablet and oral solution): Cmax

  From 0 to 120 hours after sotagliflozin intake

• Sotagliflozin-O-glucuronide (tablet and oral solution): tmax

  From 0 to 120 hours after sotagliflozin intake

Study Arms (3)

Fed Tablet period (Test, T)

EXPERIMENTAL

Sotagliflozin oral in fed conditions

Drug: Sotagliflozin (SAR439954)

Fasted Tablet period (Reference, R)

EXPERIMENTAL

Sotagliflozin oral in fasting conditions

Drug: Sotagliflozin (SAR439954)

Oral Solution period (S)

EXPERIMENTAL

Sotagliflozin oral solution in fasting conditions

Drug: Sotagliflozin (SAR439954)

Interventions

Sotagliflozin (SAR439954) DRUG

Pharmaceutical form: tablet Route of administration: oral

Fasted Tablet period (Reference, R); Fed Tablet period (Test, T)

Eligibility Criteria

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

You may qualify if:

• Healthy male and female subjects, between 18 and 55 years of age, inclusive, at the time of screening.
• 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), vital signs, ECG, and clinical laboratory parameters.

You may not qualify if:

• 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 (more than twice a month).
• 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.
• 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 826001

Leeds, LS2 9LH, United Kingdom

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

Condition Hierarchy (Ancestors)

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: May 31, 2017
• First Posted: June 2, 2017
• Study Start: June 12, 2017
• Primary Completion: September 15, 2017
• Study Completion: September 15, 2017
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)