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.
The expected duration of the study is approximately 59 days per subject, including 2-28 days of screening, treatment period 1 of 7 days, treatment period 2 of 8 days, at least 7 days of wash-out period, and an end of study visit, which is between 14-21 days after the last dose of sotagliflozin.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
16
Pharmaceutical form: tablet Route of administration: oral
Pharmaceutical form: capsule Route of administration: oral
Investigational site 250001
Gières, France
Maximum plasma concentration (Cmax)
Time frame: Up to 144 hours after each SAR439954 intake
Area under the concentration-time curve from 0 to the last quantifiable concentration (AUClast)
Time frame: Up to 144 hours after each SAR439954 intake
Area under the concentration-time curve from 0 to infinity (AUC0 ∞)
Time frame: Up to 144 hours after each SAR439954 intake
Total 24-hour UGE (urinary glucose excretion) after each dose with sotagliflozin
Time frame: Up to 24 hours after each SAR439954 intake
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