A Study to Assess the Effects of Cyclosporine on the Pharmacokinetics and Safety of Canagliflozin (JNJ-28431754) in Healthy Volunteers
|ClinicalTrials.gov Identifier: NCT01718652|
Recruitment Status : Completed
First Posted : October 31, 2012
Last Update Posted : November 27, 2012
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Canagliflozin (JNJ-28431754) Drug: Cyclosporine||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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-28431754Drug: Cyclosporine
Four 100 mg capsules (400 mg total dose) taken orally 30 minutes before the last dose of canagliflozin (JNJ-28431754) on Day 8.
- 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.
- The number of volunteers with adverse events as a measure of safety and tolerability [ Time Frame: Up to 47 days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01718652
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development,L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|