A Pharmacokinetic and Pharmacodynamic Study of Once-Daily and Twice-Daily Dosing With Canagliflozin in Healthy Adult Volunteers
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT01286103
- Brief Summary
The purpose of this study is to evaluate the effects of canagliflozin on glucose levels in the blood and urine when taken at 2 dose levels as a once-daily or twice-daily dosing regimen in healthy adult volunteers
- Detailed Description
This is an open-label (volunteers will know the names of treatments they are 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). Patients in Cohort 1 will be randomized to receive Treatment A (one 300-mg tablet orally, by mouth \[PO\] once daily for 5 days) followed 10 days later by Treatment B (one 50-mg and one 100-mg tablet PO twice daily for 5 days) or Treatment B followed by Treatment A. Patients in Cohort 2 will be randomized to receive Treatment C (one 100-mg tablet PO once daily for 5 days) followed 10 days later by Treatment D (one 50-mg tablet PO twice daily for 5 days) or Treatment D followed by Treatment C.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
- 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 lactose
- Known allergy to canagliflozin or any of the excipients of the formulation of canagliflozin
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 002 Canagliflozin 100 mg once daily and 50 mg twice daily Canagliflozin 100 mg once daily and 50 mg twice daily Treatment C (one 100-mg tablet once daily for 5 days) followed 10 days later by Treatment D (one 50-mg tablet twice daily for 5 days) or Treatment D followed by Treatment C. 001 Canagliflozin 300 mg once daily and 150 mg twice daily Canagliflozin 300 mg once daily and 150 mg twice daily Treatment A (one 300-mg tablet once daily for 5 days) followed 10 days later by Treatment B (one 50-mg and one 100-mg tablet twice daily for 5 days) or Treatment B followed by Treatment A.
- Primary Outcome Measures
Name Time Method Plasma concentrations of canagliflozin Up to Day 5 after the last treatment Plasma concentrations of glucose Up to Day 5 after the last treatment Urinary glucose excretion (UGE) Up to Day 5 after the last treatment Renal threshold of glucose (RTG) Up to Day 5 after the last treatment
- 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 8) Changes in hematology laboratory parameters Up to 10 days after last dose (last dose is given on Day 8) Changes in chemistry laboratory parameters Up to 10 days after last dose (last dose is given on Day 8)