A Study to Assess the Pharmacokinetics, Pharmacodynamics, and Safety of Canagliflozin (JNJ-28431754) in Volunteers With Varying Degrees of Kidney Function

Part of paid clinical trials in Orlando, Florida.

Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study ID
NCT01759576
Phase
PHASE1
Status
Completed

Conditions

  • Healthy
  • Renal Insufficiency

Eligibility Criteria

Sex
ALL
Age
18 Years - 79 Years
Healthy Volunteers
Accepted

Interventions

  • Canagliflozin (JNJ-28431754) — DRUG
    Volunteers in groups 1 through 4 will receive one 200mg tablet orally (by mouth) on Day 1. Volunteers in group 5 will receive one 200mg tablet orally on Day 1 (one hour after hemodialysis) followed, approximately 10 days later, by one 200mg tablet orally (2 hours before hemodialysis).

Study Details

The purpose of this study is to assess the pharmacokinetics (ie, how the body affects the drug) and pharmacodynamics (ie, how the drug affects the body) of canagliflozin (JNJ-28431754) after administration of a single dose to non-diabetic volunteers with normal kidney function and non-diabetic volunteers with varying degrees of kidney impairment (including volunteers with end-stage renal disease requiring hemodialysis).

Key Dates

Start date
Mar 31, 2008
Status verified
May 2013
Primary completion
Nov 30, 2008
Completion
Nov 30, 2008

Study Design

Enrollment
40 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1 (normal kidney function)
    Each volunteer will receive a single dose of canagliflozin (JNJ-28431754) on Day 1
  • Experimental: Group 2 (mild kidney impairment)
    Each volunteer will receive a single dose of canagliflozin (JNJ-28431754) on Day 1
  • Experimental: Group 3 (moderate kidney impairment)
    Each volunteer will receive a single dose of canagliflozin (JNJ-28431754) on Day 1
  • Experimental: Group 4 (severe kidney impairment)
    Each volunteer will receive a single dose of canagliflozin (JNJ-28431754) on Day 1
  • Experimental: Group 5 (hemodialysis)
    Each volunteer will receive a single dose of canagliflozin (JNJ-28431754) on Day 1 following completion of hemodialysis. Approximately 10 days later, each volunteer will receive another single dose of canagliflozin before hemodialysis begins.

Primary Outcome Measure

Plasma concentrations of canagliflozin (JNJ-28431754) in varying degrees of kidney function [ Time Frame: Up to Day 6 ]

Locations (3)

FacilityCityStateZIPSite coordinators
-OrlandoFlorida--
-MinneapolisMinnesota--
-KnoxvilleTennessee--

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