PK Study of Sotagliflozin in Subjects With Hepatic Impairment

Part of paid clinical trials in Lakewood, Colorado.

Sponsor
Lexicon Pharmaceuticals
Study ID
NCT02471274
Phase
PHASE1
Status
Completed

Conditions

  • Healthy
  • Hepatic Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

First listed
Jun 15, 2015
Start date
Jun 30, 2015
Status verified
Nov 2016
Primary completion
Dec 31, 2015

Study Design

Enrollment
32 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1
    healthy control subjects with normal hepatic function
  • Experimental: Group 2
    subjects with mild hepatic impairment
  • Experimental: Group 3
    subjects with moderate hepatic impairment
  • Experimental: Group 4
    subjects with severe hepatic impairment

Primary Outcome Measure

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

Locations (4)

FacilityCityStateZIPSite coordinators
Lexicon Investigational SiteLakewoodColorado80228-
Lexicon Investigational SiteMiamiFlorida33014-
Lexicon Investigational SiteOrlandoFlorida32809-
Lexicon Investigational SiteMinneapolisMinnesota55404-

Find similar trials in Lakewood, CO

By research site
Lexicon Investigational Site· Lakewood, COLexicon Investigational Site· Miami, FLLexicon Investigational Site· Orlando, FLLexicon Investigational Site· Minneapolis, MN

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