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

Part of paid clinical trials in Miami, Florida.

Sponsor
Lexicon Pharmaceuticals
Study ID
NCT02647918
Phase
PHASE1
Status
Completed

Conditions

  • Healthy
  • Renal Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

Start date
Dec 31, 2015
Status verified
Feb 2019
Primary completion
Sep 30, 2017
Completion
Sep 30, 2017

Study Design

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

Arms

  • Experimental: Group 1
    Subjects with normal renal function
  • Experimental: Group 2
    Subjects with mild renal impairment
  • Experimental: Group 3
    Subjects with moderate renal impairment
  • Experimental: Group 4
    Subjects with severe renal impairment
  • Experimental: Group 5
    Subjects with ESRD requiring HD

Primary Outcome Measure

Number of treatment emergent adverse events [ Time Frame: Day 1 to Day 8 ]

Locations (4)

FacilityCityStateZIPSite coordinators
Lexicon Investigational SiteMiamiFlorida33014-
Lexicon Investigational SiteOrlandoFlorida32809-
Lexicon Investigational SiteMinneapolisMinnesota55404-
Lexicon Investigational SiteSaint PaulMinnesota55114-

Find similar trials in Miami, FL

By research site
Lexicon Investigational Site· Miami, FLLexicon Investigational Site· Orlando, FLLexicon Investigational Site· Minneapolis, MNLexicon Investigational Site· Saint Paul, MN

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