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

Phase 1

Completed

• Conditions: Diabetes Mellitus
• Interventions: Drug: Sotagliflozin (SAR439954)

• Registration Number: NCT03174548
• Lead Sponsor: Sanofi

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.

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.

Study Timeline

• Study First Submitted: 2017-05-31
• Study First Submitted QC: 2017-06-01
• Study First Posted: 2017-06-02
• Study Start: 2017-06-12
• Primary Completion: 2017-09-15
• Study Completion: 2017-09-15
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Oral Solution period (S)	Sotagliflozin (SAR439954)	Sotagliflozin oral solution in fasting conditions
Fed Tablet period (Test, T)	Sotagliflozin (SAR439954)	Sotagliflozin oral in fed conditions
Fasted Tablet period (Reference, R)	Sotagliflozin (SAR439954)	Sotagliflozin oral in fasting conditions

Primary Outcome Measures

Name	Time	Method
Area under curve (AUC) of sotagliflozin	From 0 to 120 hours after sotagliflozin intake
Maximum plasma drug concentration (Cmax) of sotagliflozin	From 0 to 120 hours after sotagliflozin intake

Secondary Outcome Measures

Name	Time	Method
Sotagliflozin-O-glucuronide (tablet and oral solution): Area under the plasma concentration-time curve from time zero to time of last measurable concentration (AUClast)	From 0 to 120 hours after sotagliflozin intake
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): Elimination half-life (t1/2z)	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-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
Sotagliflozin-O-glucuronide (tablet and oral solution): AUC	From 0 to 120 hours after sotagliflozin intake
Relative bioavailability (Frel)	From 0 to 120 hours after sotagliflozin intake
Number (%) of subjects with treatment emergent adverse events	Over 9 weeks
Sotagliflozin-O-glucuronide (tablet and oral solution): t1/2z	From 0 to 120 hours after sotagliflozin intake

Trial Locations

Locations (1)

Investigational Site Number 826001; 🇬🇧 Leeds, United Kingdom