Overview

This trial has been completed.

Conditions hepatic impairment, healthy
Treatment sotagliflozin
Phase phase 1
Sponsor Lexicon Pharmaceuticals
Start date June 2015
End date December 2015
Trial size 32 participants
Trial identifier NCT02471274, LX4211.1-116-HEP, LX4211.116

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
healthy control subjects with normal hepatic function
sotagliflozin
single 400 mg dose
(Experimental)
subjects with mild hepatic impairment
sotagliflozin
single 400 mg dose
(Experimental)
subjects with moderate hepatic impairment
sotagliflozin
single 400 mg dose
(Experimental)
subjects with severe hepatic impairment
sotagliflozin
single 400 mg dose

Primary Outcomes

Measure
Plasma concentration of sotaglifozin to evaluate protocol specified PK parameters
time frame: Day 1 to Day 5

Secondary Outcomes

Measure
Number of treatment emergent adverse events
time frame: Day 1 to Day 8

Eligibility Criteria

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Lexicon Pharmaceuticals.