A Study to Assess the Pharmacokinetics, Pharmacodynamics, and Safety of Canagliflozin (JNJ-28431754) in Volunteers With Varying Degrees of Kidney Function
Renal Insufficiency, Healthy
About this trial
This is an interventional treatment trial for Renal Insufficiency focused on measuring Renal Insufficiency, Healthy, Canagliflozin (JNJ-28431754), Pharmacokinetics, Pharmacodynamics, Dialysis
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Experimental
Group 1 (normal kidney function)
Group 2 (mild kidney impairment)
Group 3 (moderate kidney impairment)
Group 4 (severe kidney impairment)
Group 5 (hemodialysis)
Each volunteer will receive a single dose of canagliflozin (JNJ-28431754) on Day 1
Each volunteer will receive a single dose of canagliflozin (JNJ-28431754) on Day 1
Each volunteer will receive a single dose of canagliflozin (JNJ-28431754) on Day 1
Each volunteer will receive a single dose of canagliflozin (JNJ-28431754) on Day 1
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.