NCT03174548

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

A Phase 1, Randomized, Single-center, Open-label, Three-sequence, Three-period, Three-treatment Crossover Study to Evaluate the Effect of Food on the Single-dose Pharmacokinetics of Sotagliflozin and to Explore the Relative Bioavailability of Sotagliflozin Oral Tablet to Oral Solution in Healthy Male and Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

The study duration per subject will be 26 to 83 days and will consist of a screening period of 2-28 days, a treatment period of 6 days each for Periods 1, 2 and 3, a washout between treatment periods of 1-14 days, and follow up visit 10-15 days after the last Investigational Medicinal Product administration in period 3.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Sotagliflozin (SAR439954)	Pharmaceutical form: tablet Route of administration: oral
DRUG	Sotagliflozin (SAR439954)	Pharmaceutical form: solution Route of administration: oral

Timeline

• Start date: 2017-06-12
• Primary completion: 2017-09-15
• Completion: 2017-09-15
• First posted: 2017-06-02
• Last updated: 2022-04-25

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study