PK Study of Sotagliflozin in Subjects With Hepatic Impairment

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02471274
• Other study ID #: LX4211.1-116-HEP
• Secondary ID: LX4211.116
• Status: Completed
• Phase: Phase 1
• First received: June 11, 2015
• Last updated: November 15, 2016
• Start date: June 2015

Study information

• Verified date: November 2016
• Source: Lexicon Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy
• Hepatic Impairment
• Liver Diseases

Intervention

Drug:
• sotagliflozin
single 400 mg dose

Locations

Country	Name	City	State
United States	Lexicon Investigational Site	Lakewood	Colorado
United States	Lexicon Investigational Site	Miami	Florida
United States	Lexicon Investigational Site	Minneapolis	Minnesota
United States	Lexicon Investigational Site	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Lexicon Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentration of sotaglifozin to evaluate protocol specified PK parameters		Day 1 to Day 5	No
Secondary	Number of treatment emergent adverse events		Day 1 to Day 8	Yes