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PK Study of Sotagliflozin in Subjects With Hepatic Impairment

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ClinicalTrials.gov Identifier: NCT02471274
Recruitment Status : Completed
First Posted : June 15, 2015
Last Update Posted : November 17, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hepatic Impairment Healthy Drug: sotagliflozin Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : June 2015
Actual Primary Completion Date : December 2015

Arm Intervention/treatment
Experimental: Group 1
healthy control subjects with normal hepatic function
Drug: sotagliflozin
single 400 mg dose

Experimental: Group 2
subjects with mild hepatic impairment
Drug: sotagliflozin
single 400 mg dose

Experimental: Group 3
subjects with moderate hepatic impairment
Drug: sotagliflozin
single 400 mg dose

Experimental: Group 4
subjects with severe hepatic impairment
Drug: sotagliflozin
single 400 mg dose




Primary Outcome Measures :
  1. Plasma concentration of sotaglifozin to evaluate protocol specified PK parameters [ Time Frame: Day 1 to Day 5 ]

Secondary Outcome Measures :
  1. Number of treatment emergent adverse events [ Time Frame: Day 1 to Day 8 ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02471274


Locations
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United States, Colorado
Lexicon Investigational Site
Lakewood, Colorado, United States, 80228
United States, Florida
Lexicon Investigational Site
Miami, Florida, United States, 33014
Lexicon Investigational Site
Orlando, Florida, United States, 32809
United States, Minnesota
Lexicon Investigational Site
Minneapolis, Minnesota, United States, 55404
Sponsors and Collaborators
Lexicon Pharmaceuticals
Investigators
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Study Director: Suman Wason, MD Lexicon Pharmaceuticals, Inc.

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Responsible Party: Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02471274     History of Changes
Other Study ID Numbers: LX4211.1-116-HEP
LX4211.116 ( Other Identifier: Lexicon Pharmaceuticals, Inc. )
First Posted: June 15, 2015    Key Record Dates
Last Update Posted: November 17, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
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Liver Diseases
Digestive System Diseases
(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs