A Single and Multiple Dose Study of Canagliflozin in Healthy Volunteers
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT01281579
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 27
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 003 Canagliflozin 300 mg Canagliflozin 300 mg Tablets oral 300-mg once daily on Day 1 and on Days 4 through 9. 001 Canagliflozin 50 mg Canagliflozin 50 mg Tablets oral 50-mg once daily on Day 1 and on Days 4 through 9. 002 Canagliflozin 100 mg Canagliflozin 100 mg Tablets oral 100-mg once daily on Day 1 and on Days 4 through 9.
- Primary Outcome Measures
Name Time Method Plasma concentrations of canagliflozin At protocol-specified times up to Day 14 Urine concentrations of canagliflozin At protocol-specified times up to Day 11 Plasma glucose concentrations At protocol-specified times up to Day 11 Urine glucose concentrations At protocol-specified times up to Day 11
- Secondary Outcome Measures
Name Time Method The number and type of adverse events reported Up to 10 days after last dose" (last dose is given on Day 9) Changes in hematology, chemistry and urinalysis parameters Up to 10 days after last dose" (last dose is given on Day 9)