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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT01718652
First received: October 29, 2012
Last updated: November 22, 2012
Last verified: November 2012

October 29, 2012
November 22, 2012
February 2011
April 2011   (final data collection date for primary outcome measure)
Plasma concentrations of canagliflozin (JNJ-28431754) [ Time Frame: Day 7 and Day 8 ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01718652 on ClinicalTrials.gov Archive Site
The number of volunteers with adverse events as a measure of safety and tolerability [ Time Frame: Up to 47 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study to Assess the Effects of Cyclosporine on the Pharmacokinetics and Safety of Canagliflozin (JNJ-28431754) in Healthy Volunteers
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

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.

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.

Interventional
Phase 1
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
  • 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.
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.
Interventions:
  • Drug: Canagliflozin (JNJ-28431754)
  • Drug: Cyclosporine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
April 2011
April 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01718652
CR017926, 28431754DIA1031, 2010-021854-21
No
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Not Provided
Study Director: Johnson & Johnson Pharmaceutical Research & Development,L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP