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Completed Phase 1 Interventional Accepts healthy volunteers

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

ClinicalTrials.gov ID: NCT02647918

Public ClinicalTrials.gov record NCT02647918. 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 21, 2026, 7:41 AM 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 Sotagliflozin Safety and Pharmacokinetics in Subjects With Varying Degrees of Renal Function

Brief summary

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

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 identification

NCT ID
NCT02647918
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Lexicon Pharmaceuticals
Industry
Enrollment
50 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 75 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
Dec 2015 (Actual)
Primary completion
Sep 2017 (Actual)
Completion
Sep 2017 (Actual)
Last update posted
Feb 26, 2019

2015 – 2017

United States locations

U.S. sites
4
U.S. states
2
U.S. cities
4
Facility City State ZIP Site status
Lexicon Investigational Site Miami Florida 33014 —
Lexicon Investigational Site Orlando Florida 32809 —
Lexicon Investigational Site Minneapolis Minnesota 55404 —
Lexicon Investigational Site Saint Paul Minnesota 55114 —

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 NCT02647918, 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 Feb 26, 2019 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02647918 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →