Study to Evaluate Sotagliflozin in Subjects With Varying Degrees of Renal Function

Status:	Completed
Conditions:	Healthy Studies, Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:	Nephrology / Urology, Other
Healthy:	No
Age Range:	18 - 75
Updated:	2/28/2019
Start Date:	December 2015
End Date:	September 2017

A Phase 1, Open-label, Parallel-group Study to Evaluate Sotagliflozin Safety and Pharmacokinetics in Subjects With Varying Degrees of Renal Function

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.

Inclusion Criteria:

- Adult male and female subjects ≥18 to ≤75 years of age

- Body mass index ≥18.0 to ≤36.0 kg/m2, at Screening

- Subjects with mild, moderate, or severe renal impairment, or ESRD requiring HD

- Control group of matched healthy subjects

- Willing and able to provide written informed consent

Exclusion Criteria:

- Presence of clinically significant physical, laboratory, or ECG findings that may
interfere with any aspect of study conduct or interpretation of results

- Existence of any surgical or medical condition that might interfere with the
absorption, distribution, metabolism, or excretion of sotagliflozin

- History of any major surgery within 6 months

- History of hepatic disease, or significantly abnormal liver function test

- Women who are breastfeeding or are planning to become pregnant during the study

We found this trial at

sites

Lexicon Investigational Site

Miami, Florida 33014

from

Miami, FL