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

Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus; Healthy Subjects
• Interventions: Drug: sotagliflozin (SAR439954)

• Registration Number: NCT03776227
• Lead Sponsor: Sanofi

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

Detailed Description

Study duration per participant is approximately 103 days including a screening period up to 21 days before first dose, 4 periods of dosing and pharmacokinetic (PK) sampling each lasting 7 days, a washout period of 8-21 days between dosing, and an end of study visit 10-15 days after the last dose.

Study Timeline

• Study First Submitted: 2018-12-12
• Study First Submitted QC: 2018-12-12
• Study First Posted: 2018-12-14
• Study Start: 2019-01-25
• Primary Completion: 2019-04-22
• Study Completion: 2019-04-22
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sotagliflozin Reference	sotagliflozin (SAR439954)	Two tablets of sotagliflozin administered orally under fasting conditions
Sotagliflozin Test	sotagliflozin (SAR439954)	One tablet of sotagliflozin administered orally under fasting conditions

Primary Outcome Measures

Name	Time	Method
AUC 0-72h (area under the curve)	Day 1 to Day 3 of each period	Truncated AUC 0-72h
Cmax	Day 1 of each period	Maximum plasma concentration observed

Secondary Outcome Measures

Name	Time	Method
Clinical laboratory tests	Day 1 to Day 7 of each period	Number of patients with clinically significant changes in clinical laboratory tests
Time to reach Cmax (tmax)	Day 1 of each period	Time to reach Cmax
Terminal half-life (t1/2z)	Day 1 to Day 7 of each period	Terminal half-life associated with the terminal slope (λz)
Electrocardiograms (ECGs)	Day 1 to Day 7 of each period	Number of patients with clinically significant changes in electrocardiograms (ECGs)
Area under the curve (AUC)	Day 1 to Day 7 of each period	Area under the plasma concentration versus time curve extrapolated to infinity
Area under the plasma concentration versus time curve (AUClast)	Day 1 to Day 7 of each period	Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to the real time tlast
Adverse events	Day 1 to Day 7 of each period	Number of participants with adverse events
Vital signs	Day 1 to Day 7 of each period	Number of patients with clinically significant changes in vital signs

Trial Locations

Locations (1)

Investigational Site Number 8400001; 🇺🇸 Miami, Florida, United States