drugset / Trial / NCT03174548

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

NCT03174548

Phase 1 Completed 14 enrolled Sanofi
RandomizedCrossoverOpen-labelTreatment

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.

Timeline

Start
2017-06-12
Primary completion
2017-09-15
Completion
2017-09-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Sotagliflozin Small molecule Oral

Indications