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COMPLETEDPhase 1NCT02471274

PK Study of Sotagliflozin in Subjects With Hepatic Impairment

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...

Lead sponsor: Lexicon Pharmaceuticals•4 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Lexicon Pharmaceuticals

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Yes

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: November 17, 2016Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE1

Enrollment32

Start dateJun 2015

Last updatedNov 17, 2016

Condition

Hepatic Impairment Healthy

Locations shown

Lexicon Investigational Site

Lakewood, Colorado

Lexicon Investigational Site

Miami, Florida

Lexicon Investigational Site

Orlando, Florida

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 17, 2016Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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