NCT01759576

A Study to Assess the Pharmacokinetics, Pharmacodynamics, and Safety of Canagliflozin (JNJ-28431754) in Volunteers With Varying Degrees of Kidney Function

An Open-Label, Single-Dose Study to Evaluate JNJ-28431754 Pharmacokinetics, Pharmacodynamics and Safety in Non-Diabetic Subjects With Varying Degrees of Renal Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the pharmacokinetics (ie, how the body affects the drug) and pharmacodynamics (ie, how the drug affects the body) of canagliflozin (JNJ-28431754) after administration of a single dose to non-diabetic volunteers with normal kidney function and non-diabetic volunteers with varying degrees of kidney impairment (including volunteers with end-stage renal disease requiring hemodialysis).

Detailed description

This study will be an open label (all volunteers and study staff know the identity of the assigned treatment), single-dose, multicenter (the study will be conducted at more than one center), parallel-group study (each group of volunteers will be treated at the same time) to assess the pharmacokinetics and pharmacodynamics of canagliflozin (a drug currently being investigated for the treatment of type 2 diabetes mellitus) in volunteers with varying degrees of kidney function. The study will consist of 3 phases: a screening phase, an open-label treatment phase, and an end-of study (or follow-up) phase. Volunteers will be assigned to 1 of 5 groups (depending on kidney function): group 1 will have normal kidney function; group 2 will have mild kidney impairment; group 3 will have moderate kidney impairment; group 4 will have severe kidney impairment; and group 5 will comprise volunteers requiring hemodialysis. Volunteers in groups 1 through 4 will receive a single dose of canagliflozin on Day 1. Volunteers in group 5 will receive a single dose of canagliflozin following dialysis and then, approximately 10 days later, they will receive a second dose before dialysis. Volunteers in groups 1 through 4 will participate in the study for 27 days. Volunteers in group 5 will participate in the study for 40 days.

Conditions

• Renal Insufficiency
• Healthy

Interventions

Type	Name	Description
DRUG	Canagliflozin (JNJ-28431754)	Volunteers in groups 1 through 4 will receive one 200mg tablet orally (by mouth) on Day 1. Volunteers in group 5 will receive one 200mg tablet orally on Day 1 (one hour after hemodialysis) followed, approximately 10 days later, by one 200mg tablet orally (2 hours before hemodialysis).

Timeline

• Start date: 2008-03-01
• Primary completion: 2008-11-01
• Completion: 2008-11-01
• First posted: 2013-01-03
• Last updated: 2013-05-29

Locations

3 sites across 1 country: United States