NCT01281579

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Canagliflozin 100 mg	Tablets, oral, 100-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.
DRUG	Canagliflozin 300 mg	Tablets, oral, 300-mg, once daily on Day 1 and on Days 4 through 9.

Timeline

• Start date: 2011-01-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2011-01-24
• Last updated: 2012-11-30