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

Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study ID
NCT01718652
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Canagliflozin (JNJ-28431754) — DRUG
    One 300 mg capsule-shaped tablet taken orally (by mouth) on Days 1 through 8.
  • 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.

Study Details

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.

Key Dates

Start date
Feb 28, 2011
Status verified
Nov 2012
Primary completion
Apr 30, 2011
Completion
Apr 30, 2011

Study Design

Enrollment
18 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Plasma concentrations of canagliflozin (JNJ-28431754) [ Time Frame: Day 7 and Day 8 ]

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