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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02647918
• Other study ID #: LX4211.1-121-REN
• Secondary ID: LX4211.121
• Status: Completed
• Phase: Phase 1
• Start date: December 2015
• Est. completion date: September 2017

Study information

• Verified date: February 2019
• Source: Lexicon Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Renal Impairment
• Renal Insufficiency

Intervention

Drug:
• Sotagliflozin
Single dose
• Sotagliflozin
2 single doses

Locations

Country	Name	City	State
United States	Lexicon Investigational Site	Miami	Florida
United States	Lexicon Investigational Site	Minneapolis	Minnesota
United States	Lexicon Investigational Site	Orlando	Florida
United States	Lexicon Investigational Site	Saint Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Lexicon Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of treatment emergent adverse events		Day 1 to Day 8
Secondary	Plasma concentration of sotaglifozin to evaluate AUC		Day 1