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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01718652
Recruitment Status : Completed
First Posted : October 31, 2012
Last Update Posted : November 27, 2012
Information provided by (Responsible Party):
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.

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
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 : February 2011
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: 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.

Primary Outcome Measures :
  1. Plasma concentrations of canagliflozin (JNJ-28431754) [ Time Frame: 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 :
  1. The number of volunteers with adverse events as a measure of safety and tolerability [ Time Frame: Up to 47 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01718652

Antwerpen, Belgium
Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Director: Johnson & Johnson Pharmaceutical Research & Development,L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Identifier: NCT01718652     History of Changes
Other Study ID Numbers: CR017926
28431754DIA1031 ( Other Identifier: Johnson & Johnson Pharmaceutical Research & Development, L.L.C )
2010-021854-21 ( EudraCT Number )
First Posted: October 31, 2012    Key Record Dates
Last Update Posted: November 27, 2012
Last Verified: November 2012

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Canagliflozin (JNJ-28431754)

Additional relevant MeSH terms:
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors
Hypoglycemic Agents