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

NCT01718652 | Completed Phase 1

• 3 other identifiers: CR01792628431754DIA10312010-021854-21
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Healthy; Canagliflozin (JNJ-28431754); Pharmacokinetics; Cyclosporine

Outcome Measures

Primary Outcomes (1)

• Plasma concentrations of canagliflozin (JNJ-28431754)

  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.

  Day 7 and Day 8

Secondary Outcomes (1)

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

  Up to 47 days

Study Arms (1)

Canagliflozin + cyclosporine

EXPERIMENTAL

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); Drug: Cyclosporine

Interventions

Canagliflozin (JNJ-28431754) DRUG

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

Also known as: JNJ-28431754

Canagliflozin + cyclosporine

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.

Canagliflozin + cyclosporine

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Study Sites (1)

Unknown Facility

Antwerp, Belgium

Location

MeSH Terms

Interventions

Canagliflozin; Cyclosporine

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glucosides; Glycosides; Carbohydrates; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

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

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2012
• First Posted: October 31, 2012
• Study Start: February 1, 2011
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: November 27, 2012

Record last verified: 2012-11

Locations

BE (1)