Study To Determine Bioavailability of Sotagliflozin in Healthy Male and Female Subjects
Status:
Completed
Trial end date:
2019-03-28
Target enrollment:
Participant gender:
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