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

• Status: Completed
• Trial end date: 2017-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Lexicon Pharmaceuticals
• Treatments: (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol

Criteria

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