drugset / Trial / NCT02940379

A Drug to Drug Interaction Study of Sotagliflozin With Midazolam and Metoprolol

NCT02940379

Phase 1 Completed 24 enrolled Sanofi
Non-randomizedParallel-groupOpen-labelTreatment

Summary

Primary Objective: To assess the effect of repeated once-daily oral doses of sotagliflozin on CYP2D6 and CYP3A activities using a CYP probe cocktail of metoprolol and midazolam. Secondary Objective: To assess the clinical and laboratory safety of sotagliflozin coadministered with the cocktail probes as compared to that of cocktail probes alone.

Timeline

Start
2016-10
Primary completion
2016-12
Completion
2016-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Metoprolol Other / unclassified Oral
Subject Midazolam Small molecule Oral
Subject Sotagliflozin Small molecule Oral