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OpenTrials
Completed

NCT Number: NCT02471274

PK Study of Sotagliflozin in Subjects With Hepatic Impairment

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.

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Key information

Conditions

Hepatic Impairment Healthy

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Lexicon Investigational Site, Lakewood, Colorado, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sotagliflozin

Drug

single 400 mg dose

Primary outcomes

  1. Plasma concentration of sotaglifozin to evaluate protocol specified PK parameters

    Time frame: Day 1 to Day 5

Secondary outcomes

  1. Number of treatment emergent adverse events

    Time frame: Day 1 to Day 8

Sponsors and collaborators

Lead sponsor

Lexicon Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
First posted
Jun 15, 2015
Registry last updated
Nov 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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