Study To Determine Bioavailability of Sotagliflozin in Healthy Male and Female Subjects

Summary

Primary Objective: To assess the absolute bioavailability of sotagliflozin via administration of an intravenous (IV) microdose of a 14C-sotagliflozin tracer on top of a single oral dose of unlabeled sotagliflozin without charcoal administration Secondary Objectives: * To assess the PK of sotagliflozin and its main metabolite sotagliflozin-3-O-glucuronide (M19) after a single oral dose of sotagliflozin and an IV microdose of a 14C-sotagliflozin tracer without charcoal administration * To assess the safety and tolerability of single doses of sotagliflozin when administered with and without charcoal

Timeline

Start

2019-01-14

Primary completion

2019-03-28

Completion

2019-03-28

Drugs

Indications