A Single and Multiple Dose Study of Canagliflozin in Healthy Volunteers

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Canagliflozin 100 mg
* Drug: Canagliflozin 50 mg
* Drug: Canagliflozin 300 mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 001<br>Canagliflozin 50 mg Tablets oral 50-mg once daily on Day 1 and on Days 4 through 9. | Drug: Canagliflozin 50 mg<br>* Tablets, oral, 50-mg, once daily on Day 1 and on Days 4 through 9.<br>|
| Experimental: 002<br>Canagliflozin 100 mg Tablets oral 100-mg once daily on Day 1 and on Days 4 through 9. | Drug: Canagliflozin 100 mg<br>* Tablets, oral, 100-mg, once daily on Day 1 and on Days 4 through 9.<br>|
| Experimental: 003<br>Canagliflozin 300 mg Tablets oral 300-mg once daily on Day 1 and on Days 4 through 9. | Drug: Canagliflozin 300 mg<br>* Tablets, oral, 300-mg, once daily on Day 1 and on Days 4 through 9.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetics, Pharmacodynamics, Canagliflozin