A Study of Canagliflozin in Study Participants With Various Degrees of Impaired Hepatic (Liver) Function

Part of paid clinical trials in Orlando, Florida.

Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study ID
NCT01186588
Phase
PHASE1
Status
Completed

Conditions

  • Healthy
  • Hepatic Insufficiency

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

Study Details

The purpose of the study is to determine the concentration of canagliflozin in blood and urine samples after the administration of canagliflozin to study participants with mild or moderate hepatic (liver) impairment compared with study participants with normal hepatic function.

Key Dates

Start date
Aug 31, 2010
Status verified
May 2013
Primary completion
Apr 30, 2011
Completion
Apr 30, 2011

Study Design

Enrollment
24 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL

Arms

  • Experimental: 001
    Canagliflozin One 300-mg dose of canagliflozin on Day 1

Primary Outcome Measure

Plasma concentrations of canagliflozin to evaluate protocol-specified pharmacokinetic parameters [ Time Frame: At protocol-specified time points before and after dosing on Day 1 through Day 6 ]

Locations (2)

FacilityCityStateZIPSite coordinators
-OrlandoFlorida--
-KnoxvilleTennessee--

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