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

NCT02647918 | Completed Phase 1

• 2 other identifiers: LX4211.1-121-RENLX4211.121
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 4

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.

Conditions

Renal Impairment; Healthy

Outcome Measures

Primary Outcomes (1)

• Number of treatment emergent adverse events

  Day 1 to Day 8

Secondary Outcomes (1)

• Plasma concentration of sotaglifozin to evaluate AUC

  Day 1

Study Arms (5)

Group 1

EXPERIMENTAL

Subjects with normal renal function

Drug: Sotagliflozin

Group 2

EXPERIMENTAL

Subjects with mild renal impairment

Drug: Sotagliflozin

Group 3

EXPERIMENTAL

Subjects with moderate renal impairment

Drug: Sotagliflozin

Group 4

EXPERIMENTAL

Subjects with severe renal impairment

Drug: Sotagliflozin

Group 5

EXPERIMENTAL

Subjects with ESRD requiring HD

Drug: Sotagliflozin

Interventions

Sotagliflozin DRUG

Single dose

Group 1; Group 2; Group 3; Group 4

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Lexicon Pharmaceuticals: lead

Study Sites (4)

Lexicon Investigational Site

Miami, Florida, 33014, United States

Location

Lexicon Investigational Site

Orlando, Florida, 32809, United States

Location

Lexicon Investigational Site

Minneapolis, Minnesota, 55404, United States

Location

Lexicon Investigational Site

Saint Paul, Minnesota, 55114, United States

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Suman Wason, MD

  Lexicon Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2015
• First Posted: January 6, 2016
• Study Start: December 1, 2015
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: February 26, 2019

Record last verified: 2019-02

Locations

US (4)