A Single and Multiple Dose Study of Canagliflozin in Healthy Volunteers

An Open-Label, Randomized, Parallel-Group, Single-Center Study to Evaluate the Single and Multiple Dose Pharmacokinetic and Pharmacodynamic Characteristics of JNJ-28431754 (Canagliflozin) in Healthy Subjects

The purpose of this study is to determine blood and urine concentrations of canagliflozin and glucose in healthy adult volunteers after administration of single and multiple doses of canagliflozin.

This is an open-label (volunteers and study staff will know the name and dose of the treatment assigned), single-center study of canagliflozin (JNJ-28431754) in healthy adult volunteers. Canagliflozin (a sodium-glucose cotransporter 2-inhibitor) is currently under development to lower blood sugar levels in patients with Type 2 diabetes mellitus (T2DM). Healthy volunteers will take canagliflozin 50 mg, 100 mg, or 300 mg tablets, orally (by mouth), once daily on Day 1 and on Days 4 to 9. All study drug administration will occur at approximately the same time each morning with 240 mL of noncarbonated water and will be followed by a standardized breakfast within 10 minutes.

Inclusion Criteria:

• Healthy volunteers with a body mass index (BMI, a measure of a person's weight in relation to height) between 18 and 30 kg/m2, inclusive, and a body weight of not less than 50 kg

Exclusion Criteria:

• History of or current clinically significant medical illness as determined by the Investigator
• History of clinically significant allergies, especially known hypersensitivity or intolerance to drugs or lactose
• Known allergy to canagliflozin or any of the excipients of the formulation of canagliflozin