PK Study of Sotagliflozin in Subjects With Hepatic Impairment

Phase 1

Completed

• Conditions: Hepatic Impairment; Healthy
• Interventions: Drug: sotagliflozin

• Registration Number: NCT02471274
• Lead Sponsor: Lexicon Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-11
• Study First Submitted QC: 2015-06-12
• Study First Posted: 2015-06-15
• Primary Completion: 2015-12
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-15
• Last Update Posted: 2016-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	sotagliflozin	healthy control subjects with normal hepatic function
Group 2	sotagliflozin	subjects with mild hepatic impairment
Group 3	sotagliflozin	subjects with moderate hepatic impairment
Group 4	sotagliflozin	subjects with severe hepatic impairment

Primary Outcome Measures

Name	Time	Method
Plasma concentration of sotaglifozin to evaluate protocol specified PK parameters	Day 1 to Day 5

Secondary Outcome Measures

Name	Time	Method
Number of treatment emergent adverse events	Day 1 to Day 8

Trial Locations

Locations (1)

Lexicon Investigational Site; 🇺🇸 Minneapolis, Minnesota, United States