drugset / Trial / NCT03387657

A Drug to Drug Interaction Study of Sotagliflozin With Hydrochlorothiazide

NCT03387657

Phase 1 Completed 16 enrolled Sanofi
NaSingle-groupOpen-labelTreatment

Summary

Primary Objective: To assess the effects of multiple-dose hydrochlorothiazide (HCTZ) on the steady-state pharmacokinetics (PK) of sotagliflozin. Secondary Objectives: * To assess the safety and tolerability of multiple-dose sotagliflozin with and without co-administration of multiple-dose HCTZ * To assess the effects of multiple-dose sotagliflozin on the steady-state PK of HCTZ * To assess the effects of multiple-dose HCTZ on the steady-state PK of sotagliflozin-3-O-glucuronide

Timeline

Start
2018-01-03
Primary completion
2018-03-02
Completion
2018-03-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Hydrochlorothiazide Unknown Oral
Subject Sotagliflozin Small molecule Oral