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Completed

NCT Number: NCT02647918

Study to Evaluate Sotagliflozin in Subjects With Varying Degrees of Renal Function

The purpose of this study is to evaluate the effect of mild, moderate, or severe renal impairment, or end-stage renal disease (ESRD) requiring hemodialysis (HD), on the safety and tolerability of 1 or 2 single doses of sotagliflozin compared with healthy, demographically-matched subjects with normal renal function.

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Key information

Conditions

Renal Impairment Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Healthy Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Lexicon Investigational Site, Miami, Florida, 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 ≤75 years of age
  • Body mass index ≥18.0 to ≤36.0 kg/m2, at Screening
  • Subjects with mild, moderate, or severe renal impairment, or ESRD requiring HD
  • 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 hepatic disease, or significantly abnormal liver function test
  • Women who are breastfeeding or are planning to become pregnant during the study

Treatment and study plan

Sotagliflozin

Drug

Single dose

Primary outcomes

  1. Number of treatment emergent adverse events

    Time frame: Day 1 to Day 8

Secondary outcomes

  1. Plasma concentration of sotaglifozin to evaluate AUC

    Time frame: Day 1

Sponsors and collaborators

Lead sponsor

Lexicon Pharmaceuticals

Industry

Registry information

Official study title

A Phase 1, Open-label, Parallel-group Study to Evaluate Sotagliflozin Safety and Pharmacokinetics in Subjects With Varying Degrees of Renal Function

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jan 6, 2016
Registry last updated
Feb 26, 2019

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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