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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Canagliflozin 50 mg; Drug: Canagliflozin 100 mg; Drug: Canagliflozin 300 mg

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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: January 20, 2011
• First Submitted That Met QC Criteria: January 20, 2011
• First Posted (Estimate): January 24, 2011

Study Record Updates

• Last Update Posted (Estimate): November 30, 2012
• Last Update Submitted That Met QC Criteria: November 29, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Pharmacodynamics; Canagliflozin
• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium-Glucose Transporter 2 Inhibitors; Canagliflozin
• Other Study ID Numbers: CR017695; 28431754DIA1030

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No