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Completed Phase 1 Interventional Accepts healthy volunteers

PK Study of Sotagliflozin in Subjects With Hepatic Impairment

ClinicalTrials.gov ID: NCT02471274

Public ClinicalTrials.gov record NCT02471274. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 27, 2026, 10:44 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT02471274
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Lexicon Pharmaceuticals
Industry
Enrollment
32 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 70 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 2015 (Type not available)
Primary completion
Dec 2015 (Actual)
Completion
Not listed
Last update posted
Nov 17, 2016

Started 2015

United States locations

U.S. sites
4
U.S. states
3
U.S. cities
4
Facility City State ZIP Site status
Lexicon Investigational Site Lakewood Colorado 80228 —
Lexicon Investigational Site Miami Florida 33014 —
Lexicon Investigational Site Orlando Florida 32809 —
Lexicon Investigational Site Minneapolis Minnesota 55404 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02471274, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 17, 2016 · Synced Oct 27, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02471274 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →