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

Phase 1

Completed

• Conditions: Healthy; Renal Impairment
• Interventions: Drug: Sotagliflozin

• Registration Number: NCT02647918
• Lead Sponsor: Lexicon Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-30
• Study First Submitted QC: 2016-01-05
• Study First Posted: 2016-01-06
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-25
• Last Update Posted: 2019-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Sotagliflozin	Subjects with normal renal function
Group 3	Sotagliflozin	Subjects with moderate renal impairment
Group 2	Sotagliflozin	Subjects with mild renal impairment
Group 4	Sotagliflozin	Subjects with severe renal impairment
Group 5	Sotagliflozin	Subjects with ESRD requiring HD

Primary Outcome Measures

Name	Time	Method
Number of treatment emergent adverse events	Day 1 to Day 8

Secondary Outcome Measures

Name	Time	Method
Plasma concentration of sotaglifozin to evaluate AUC	Day 1

Trial Locations

Locations (1)

Lexicon Investigational Site; 🇺🇸 Saint Paul, Minnesota, United States