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

Completed · Phase 1

Conditions studied: Renal Impairment, Healthy

In brief

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.

Key facts

Study ID: NCT02647918
Run by: Lexicon Pharmaceuticals
People needed: 50
Starts: 2015-12-01
Expected to finish: 2017-09-01
Last updated by the study team: 2019-02-26

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.