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

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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