NCT02647918

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Lexicon Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Renal Impairment
• Healthy

Interventions

Type	Name	Description
DRUG	Sotagliflozin	Single dose
DRUG	Sotagliflozin	2 single doses

Timeline

• Start date: 2015-12-01
• Primary completion: 2017-09-01
• Completion: 2017-09-01
• First posted: 2016-01-06
• Last updated: 2019-02-26

Locations

4 sites across 1 country: United States