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

Completed · Phase 1

Conditions studied: Renal Insufficiency, Healthy

In brief

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 facts

Study ID

NCT01759576

Run by

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

People needed

40

Starts

2008-03-01

Expected to finish

2008-11-01

Last updated by the study team

2013-05-29

Who can join

Age: 18 and older, up to 79. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Volunteers must have a body mass index (BMI = weight in kg/height in m2) between 20 and 40 kg/m2 (inclusive), and body weight not less than 50 kg
• Volunteers must smoke no more than 10 cigarettes, or 2 cigars, or 2 pipes of tobacco per day for at least 6 months before first study drug administration

You may not qualify if…

• History of or currently active illness considered to be clinically significant by the Investigator or any other illness that the Investigator considers should exclude the patient from the study or that could interfere with the interpretation of the study results
• Volunteers with end stage renal disease receiving dialysis treatment other than intermittent hemodialysis
• Volunteers with end stage renal disease who have received a renal transplantation within 1 year before screening
• Volunteers with end stage renal disease diagnosed with renal carcinoma within 1 year before screening
• Volunteers with end stage renal disease receiving immunosuppressive medications, including steroids

Where it is running

• Study site — Orlando, Florida, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — Knoxville, Tennessee, United States

Full record on ClinicalTrials.gov

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