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

February 25, 2019 updated by: Lexicon Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33014
        • Lexicon Investigational Site
      • Orlando, Florida, United States, 32809
        • Lexicon Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Lexicon Investigational Site
      • Saint Paul, Minnesota, United States, 55114
        • Lexicon Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
Subjects with normal renal function
Drug: Sotagliflozin
Single dose
Drug: Sotagliflozin
2 single doses
Experimental: Group 2
Subjects with mild renal impairment
Drug: Sotagliflozin
Single dose
Drug: Sotagliflozin
2 single doses
Experimental: Group 3
Subjects with moderate renal impairment
Drug: Sotagliflozin
Single dose
Drug: Sotagliflozin
2 single doses
Experimental: Group 4
Subjects with severe renal impairment
Drug: Sotagliflozin
Single dose
Drug: Sotagliflozin
2 single doses
Experimental: Group 5
Subjects with ESRD requiring HD
Drug: Sotagliflozin
Single dose
Drug: Sotagliflozin
2 single doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of treatment emergent adverse events
Time Frame: Day 1 to Day 8
Day 1 to Day 8

Secondary Outcome Measures

Outcome Measure
Time Frame
Plasma concentration of sotaglifozin to evaluate AUC
Time Frame: Day 1
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lexicon Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2015

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

December 30, 2015

First Submitted That Met QC Criteria

January 5, 2016

First Posted (Estimate)

January 6, 2016

Study Record Updates

Last Update Posted (Actual)

February 26, 2019

Last Update Submitted That Met QC Criteria

February 25, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LX4211.1-121-REN
  • LX4211.121 (Other Identifier: Lexicon Pharmaceuticals, Inc.)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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