PK Study of Sotagliflozin in Subjects With Hepatic Impairment

November 15, 2016 updated by: Lexicon Pharmaceuticals

A Phase 1, Open-label, Parallel-group Study to Evaluate the Single-dose Pharmacokinetics of Sotagliflozin in Male and Female Subjects With Mild, Moderate, and Severe Hepatic Impairment and Matched Subjects With Normal Hepatic Function

To evaluate the effect of mild, moderate, or severe hepatic impairment on the pharmacokinetics (PK) of a single dose of 400 mg sotagliflozin (2 x 200-mg tablets) compared with healthy, demographically-matched subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

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
    • Colorado
      • Lakewood, Colorado, United States, 80228
        • Lexicon Investigational Site
    • 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

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult male and female subjects ≥18 to ≤70 years of age
  • Body mass index ≥18.0 to ≤36.0 kg/m2, inclusive, at Screening
  • Subjects with mild, moderate, or severe hepatic impairment
  • 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 renal disease, or significantly abnormal kidney 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
healthy control subjects with normal hepatic function
Drug: sotagliflozin
single 400 mg dose
Experimental: Group 2
subjects with mild hepatic impairment
Drug: sotagliflozin
single 400 mg dose
Experimental: Group 3
subjects with moderate hepatic impairment
Drug: sotagliflozin
single 400 mg dose
Experimental: Group 4
subjects with severe hepatic impairment
Drug: sotagliflozin
single 400 mg dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma concentration of sotaglifozin to evaluate protocol specified PK parameters
Time Frame: Day 1 to Day 5
Day 1 to Day 5

Secondary Outcome Measures

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

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

June 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

June 11, 2015

First Submitted That Met QC Criteria

June 12, 2015

First Posted (Estimate)

June 15, 2015

Study Record Updates

Last Update Posted (Estimate)

November 17, 2016

Last Update Submitted That Met QC Criteria

November 15, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LX4211.1-116-HEP
  • LX4211.116 (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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