PK Study of Sotagliflozin in Subjects With Hepatic Impairment

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Lexicon Pharmaceuticals
• Treatments: (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol

Criteria

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