PK Study of Sotagliflozin in Subjects With Hepatic Impairment

Completed · Phase 1

Conditions studied: Hepatic Impairment, Healthy

In brief

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.

Key facts

Study ID

NCT02471274

Run by

Lexicon Pharmaceuticals

People needed

32

Starts

2015-06-01

Last updated by the study team

2016-11-17

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Lexicon Investigational Site — Lakewood, Colorado, United States
• Lexicon Investigational Site — Miami, Florida, United States
• Lexicon Investigational Site — Orlando, Florida, United States
• Lexicon Investigational Site — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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