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

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Canagliflozin

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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