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

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (Industry)

Overall Status

Completed

CT.gov ID

NCT01718652

Collaborator

(none)

Enrollment

Location

Arm

1.9

Duration (Months)

9.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Canagliflozin (JNJ-28431754) Drug: Cyclosporine	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open-Label, Single Sequence Study to Assess the Effect of a Single Dose of Cyclosporine on the Steady-State Pharmacokinetics of JNJ-28431754 (Canagliflozin) in Healthy Adult Subjects

Study Start Date :

Feb 1, 2011

Actual Primary Completion Date :

Apr 1, 2011

Actual Study Completion Date :

Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Canagliflozin + cyclosporine Each volunteer will receive canagliflozin (JNJ-28431754) once daily on Days 1 through 8 with a single dose of cyclosporine on Day 7.	Drug: Canagliflozin (JNJ-28431754) One 300 mg capsule-shaped tablet taken orally (by mouth) on Days 1 through 8. Other Names: JNJ-28431754 Drug: Cyclosporine Four 100 mg capsules (400 mg total dose) taken orally 30 minutes before the last dose of canagliflozin (JNJ-28431754) on Day 8.

Arm

Intervention/Treatment

Experimental: Canagliflozin + cyclosporine

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

Drug: Canagliflozin (JNJ-28431754)

One 300 mg capsule-shaped tablet taken orally (by mouth) on Days 1 through 8.

Other Names:

JNJ-28431754

Drug: Cyclosporine

Four 100 mg capsules (400 mg total dose) taken orally 30 minutes before the last dose of canagliflozin (JNJ-28431754) on Day 8.

Outcome Measures

Primary Outcome Measures

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

The number of volunteers with adverse events as a measure of safety and tolerability [Up to 47 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Antwerpen		Belgium

Sponsors and Collaborators

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Investigators

Study Director: Johnson & Johnson Pharmaceutical Research & Development,L.L. C. Clinical Trial, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.