PK Study of Sotagliflozin in Subjects With Hepatic Impairment
This trial is active, not recruiting.
|Conditions||hepatic impairment, healthy|
|Start date||June 2015|
|End date||December 2015|
|Trial size||36 participants|
|Trial identifier||NCT02471274, LX4211.1-116-HEP, LX4211.116|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Lakewood, CO||Lexicon Investigational Site||no longer recruiting|
|Miami, FL||Lexicon Investigational Site||no longer recruiting|
|Orlando, FL||Lexicon Investigational Site||no longer recruiting|
|Minneapolis, MN||Lexicon Investigational Site||no longer recruiting|
|Intervention model||parallel assignment|
Plasma concentration of sotaglifozin to evaluate protocol specified PK parameters
time frame: Day 1 to Day 5
Number of treatment emergent adverse events
time frame: Day 1 to Day 8
Male or female participants from 18 years up to 70 years old.
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
|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|
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