NCT02471274

PK Study of Sotagliflozin in Subjects With Hepatic Impairment

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Lexicon Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hepatic Impairment
• Healthy

Interventions

Type	Name	Description
DRUG	sotagliflozin	single 400 mg dose

Timeline

• Start date: 2015-06-01
• Primary completion: 2015-12-01
• First posted: 2015-06-15
• Last updated: 2016-11-17

Locations

4 sites across 1 country: United States