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PK Study of Sotagliflozin in Subjects With Hepatic Impairment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE June 11, 2015
First Posted Date  ICMJE June 15, 2015
Last Update Posted Date November 17, 2016
Study Start Date  ICMJE June 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2015)
Plasma concentration of sotaglifozin to evaluate protocol specified PK parameters [ Time Frame: Day 1 to Day 5 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2015)
Number of treatment emergent adverse events [ Time Frame: Day 1 to Day 8 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PK Study of Sotagliflozin in Subjects With Hepatic Impairment
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hepatic Impairment
  • Healthy
Intervention  ICMJE Drug: sotagliflozin
single 400 mg dose
Study Arms  ICMJE
  • Experimental: Group 1
    healthy control subjects with normal hepatic function
    Intervention: Drug: sotagliflozin
  • Experimental: Group 2
    subjects with mild hepatic impairment
    Intervention: Drug: sotagliflozin
  • Experimental: Group 3
    subjects with moderate hepatic impairment
    Intervention: Drug: sotagliflozin
  • Experimental: Group 4
    subjects with severe hepatic impairment
    Intervention: Drug: sotagliflozin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 15, 2016)
32
Original Estimated Enrollment  ICMJE
 (submitted: June 12, 2015)
36
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02471274
Other Study ID Numbers  ICMJE LX4211.1-116-HEP
LX4211.116 ( Other Identifier: Lexicon Pharmaceuticals, Inc. )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lexicon Pharmaceuticals
Study Sponsor  ICMJE Lexicon Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Suman Wason, MD Lexicon Pharmaceuticals, Inc.
PRS Account Lexicon Pharmaceuticals
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP