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Completed

NCT Number: NCT01718652

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

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Antwerp, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Canagliflozin (JNJ-28431754)

Drug

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

Other names: JNJ-28431754

cyclosporine

Drug

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

Primary outcomes

  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 outcomes

  1. The number of volunteers with adverse events as a measure of safety and tolerability

    Time frame: Up to 47 days

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Oct 31, 2012
Registry last updated
Nov 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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