NCT01756417

A Study to Investigate Whether Pharmacokinetic and Pharmacodynamic Interactions Exist Between Metformin and Canagliflozin (JNJ-28431754) in Healthy Volunteers

An Open-Label, Fixed Sequence, Single and Multiple Dose Study in Male and Female Subjects to Investigate the Potential for Pharmacokinetic and Pharmacodynamic Interaction Between Metformin and JNJ-28431754

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (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 investigate whether there is a drug-drug interaction between multiple doses of canagliflozin (JNJ-28431754) and a single dose of metformin. The safety and tolerability of canagliflozin will also be assessed.

Detailed description

This study is an open-label (all volunteers and study staff know the identity of the assigned treatment), fixed sequence (all volunteers receive the same medication on the same days), single and multiple-dose study to determine how metformin (a blood glucose-lowering agent used to treat patients with diabetes) affects the pharmacokinetics (ie, how the body affects the drug) and the pharmacodynamics (ie, how the drug affects the body) of canagliflozin (a drug currently being investigated for the treatment of type 2 diabetes mellitus). The effect of canagliflozin on the pharmacokinetics and pharmacodynamics of metformin will also be evaluated. The study will consist of 3 phases: a screening phase, an open-label treatment phase, and an end-of-study (or follow-up) phase. Each volunteer will participate in the study for approximately 39 days.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Metformin	One 1,000 mg tablet of metformin taken orally (by mouth) on Day 1 and Day 8.
DRUG	Canagliflozin (JNJ-28431754)	Four 25 mg tablets of canagliflozin (JNJ-28431754) taken orally on Days 4 through 8.

Timeline

• Start date: 2007-10-01
• Primary completion: 2007-11-01
• Completion: 2007-11-01
• First posted: 2012-12-25
• Last updated: 2016-06-29

Locations

1 site across 1 country: United States