drugset / Trial / NCT03063580

Effect of Rifampicin on the Pharmacokinetics and Pharmacodynamics of Sotagliflozin

NCT03063580

Phase 1 Completed 16 enrolled Sanofi
NaSingle-groupOpen-labelBasic science

Summary

Primary Objective: To evaluate the effects of rifampicin on the pharmacokinetics (PK) of sotagliflozin and its metabolite in healthy male and female subjects. Secondary Objectives: * To assess total 24-hour urinary glucose excretion (UGE) after a dose of sotagliflozin 400 mg, alone and with rifampicin, in healthy male and female subjects. * To assess the safety and tolerability of single dose sotagliflozin with and without rifampicin in healthy male and female subjects.

Timeline

Start
2017-02-27
Primary completion
2017-05-12
Completion
2017-05-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Rifampin Small molecule 600 mg Oral
Subject Sotagliflozin Small molecule 400 mg Oral

Indications