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

NCT ID: NCT01718652

Last Updated: 2012-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-04-30

Brief Summary

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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

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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.

Conditions

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Healthy

Keywords

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Healthy Canagliflozin (JNJ-28431754) Pharmacokinetics Cyclosporine

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Canagliflozin (JNJ-28431754)

Intervention Type DRUG

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

Cyclosporine

Intervention Type DRUG

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

Interventions

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Canagliflozin (JNJ-28431754)

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

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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JNJ-28431754

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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

Role: STUDY_DIRECTOR

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

Locations

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Antwerp, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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28431754DIA1031

Identifier Type: OTHER

Identifier Source: secondary_id

2010-021854-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR017926

Identifier Type: -

Identifier Source: org_study_id