The purpose of this study is to evaluate the effect of mild, moderate, or severe renal impairment, or end-stage renal disease (ESRD) requiring hemodialysis (HD), on the safety and tolerability of 1 or 2 single doses of sotagliflozin compared with healthy, demographically-matched subjects with normal renal function.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Single dose
2 single doses
Lexicon Investigational Site
Miami, Florida, United States
Lexicon Investigational Site
Orlando, Florida, United States
Lexicon Investigational Site
Minneapolis, Minnesota, United States
Lexicon Investigational Site
Saint Paul, Minnesota, United States
Number of treatment emergent adverse events
Time frame: Day 1 to Day 8
Plasma concentration of sotaglifozin to evaluate AUC
Time frame: Day 1
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