A Study to Assess the Effects of Cyclosporine on the Pharmacokinetics and Safety of Canagliflozin (JNJ-28431754) in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Canagliflozin (JNJ-28431754); Drug: Cyclosporine

• Registration Number: NCT01718652
• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Brief Summary

The purpose of this study is to determine how a single dose of cyclosporin affects the pharmacokinetics (ie, how the body affects the drug) of multiple doses of canagliflozin (JNJ-28431754). The safety and tolerability of canagliflozin will also be assessed in healthy volunteers.

Detailed Description

This study will be an open label (all volunteers and study staff know the identity of assigned treatments), single-center, multiple-dose study to determine how cyclosporin (a drug which reduces the activity of a patient's immune system) affects the pharmacokinetics of canagliflozin (a drug currently being investigated for the treatment of type 2 diabetes mellitus). 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 47 days.

Study Timeline

• Study Start: 2011-02
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Study First Submitted: 2012-10-29
• Study First Submitted QC: 2012-10-29
• Study First Posted: 2012-10-31
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-22
• Last Update Posted: 2012-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Must have body mass index between 18 and 30 kg/m2 (inclusive), and body weight not less than 50 kg
• If a woman, must be either postmenopausal, defined as no spontaneous menses for at least 18 months or amenorrhea for at least 6 months or surgically sterile (have had a hysterectomy, or tubal ligation)

Exclusion Criteria

• History of smoking or use of nicotine-containing substances within the previous 2 months
• Have had history of or current medical illness considered to be clinically significant by the Investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Canagliflozin + cyclosporine	Canagliflozin (JNJ-28431754)	Each volunteer will receive canagliflozin (JNJ-28431754) once daily on Days 1 through 8 with a single dose of cyclosporine on Day 7.
Canagliflozin + cyclosporine	Cyclosporine	Each volunteer will receive canagliflozin (JNJ-28431754) once daily on Days 1 through 8 with a single dose of cyclosporine on Day 7.

Primary Outcome Measures

Name	Time	Method
Plasma concentrations of canagliflozin (JNJ-28431754)	Day 7 and Day 8	Comparison of the maximum plasma concentration (Cmax) and the area under the plasma concentration-time curve (AUC) of canagliflozin (JNJ-28431754) (measures of the body's exposure to canagliflozin) before and after administration of a single dose of cyclosporine. This will be used to determine whether there is a pharmacokinetic interaction between cyclosporine and canagliflozin.

Secondary Outcome Measures

Name	Time	Method
The number of volunteers with adverse events as a measure of safety and tolerability	Up to 47 days