A Study to Assess the Pharmacokinetics and Pharmacodynamics of Canagliflozin in Healthy Chinese Volunteers

Sponsor
Janssen Research & Development, LLC
Study ID
NCT01707316
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Treatment A: Canagliflozin 100 mg — DRUG
    Volunteers will receive one 100 mg over-encapsulated tablet of canagliflozin as a single oral (by mouth) dose on Day 1.
  • Treatment B: Canagliflozin 300 mg — DRUG
    Volunteers will receive one 300 mg over-encapsulated tablet of canagliflozin as a single oral dose on Day 1.
  • Treatment C: Placebo — OTHER
    Volunteers will receive one matching placebo (inactive medication) capsule as a single dose on Day 1.

Study Details

The purpose of this study is to evaluate the pharmacokinetics (what the body does to the medication) and pharmacodynamics (the action of the medication on the body) of JNJ-28431754 (canagliflozin) and its main metabolites (break-down products) following 2 different doses of canagliflozin in healthy Chinese volunteers. Safety and tolerability of canagliflozin will also be assessed.

Key Dates

Start date
Jun 30, 2012
Status verified
Feb 2013
Primary completion
Aug 31, 2012
Completion
Aug 31, 2012

Study Design

Enrollment
15 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Sequence 1: Treatment A-B-C
    The study consists of 3 single-dose treatment periods. Each treatment period will be 5 days in duration. Successive treatment periods will be separated by a washout period (with no medication) of 10 days.
  • Experimental: Sequence 2: Treatment B-C-A
    The study consists of 3 single-dose treatment periods. Each treatment period will be 5 days in duration. Successive treatment periods will be separated by a washout period (with no medication) of 10 days.
  • Experimental: Sequence 3: Treatment C-A-B
    The study consists of 3 single-dose treatment periods. Each treatment period will be 5 days in duration. Successive treatment periods will be separated by a washout period (with no medication) of 10 days.

Primary Outcome Measure

Plasma concentrations of canagliflozin and its major metabolites following a single 100 mg and 300 mg dose [ Time Frame: Up to Day 4 ]

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