drugset / Trial / NCT03070678

Interaction Study to Evaluate the Effects of Mefenamic Acid on the Pharmacokinetics and Pharmacodynamics of Sotagliflozin in Healthy Male and Female Subjects

NCT03070678

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

Summary

Primary Objective: To assess the effect of multiple dose mefenamic acid 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 400 mg sotagliflozin alone and in combination with mefenamic acid in healthy male and female subjects. * To assess the safety and tolerability of sotagliflozin alone and in combination with mefenamic acid in healthy male and female subjects.

Timeline

Start
2017-03-14
Primary completion
2017-04-18
Completion
2017-04-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Mefenamic acid Small molecule 250 mg Oral
Subject Sotagliflozin Small molecule 400 mg Oral

Indications