A Pharmacokinetic and Pharmacodynamic Study to Determine Blood Levels of JNJ-28431754 (Canagliflozin) in Patients With Type 2 Diabetes Mellitus

Part of paid clinical trials in Fort Myers, Florida.

Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study ID
NCT01128985
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
25 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Canagliflozin 50 mg — DRUG
    50 mg capsule once daily for 7 consecutive days from Day 1 to Day 7
  • Canagliflozin 100 mg — DRUG
    100 mg capsule once daily for 7 consecutive days from Day 1 to Day 7
  • Canagliflozin 300 mg — DRUG
    300 mg capsule once daily for 7 consecutive days from Day 1 to Day 7.
  • Placebo — DRUG
    matching canagliflozin placebo once daily for 7 consecutive days from Day 1 to Day 7

Study Details

The purpose of this study is to evaluate the pharmacokinetics (blood levels of the drug) and pharmacodynamics (effects of the drug on the body) of canagliflozin after oral administration to patients with type 2 diabetes mellitus.

Key Dates

Start date
Mar 31, 2010
Status verified
May 2013
Completion
Jul 31, 2010

Study Design

Enrollment
39 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 001
    Canagliflozin 50 mg 50 mg capsule once daily for 7 consecutive days from Day 1 to Day 7
  • Experimental: 002
    Canagliflozin 100 mg 100 mg capsule once daily for 7 consecutive days from Day 1 to Day 7
  • Experimental: 003
    Canagliflozin 300 mg 300 mg capsule once daily for 7 consecutive days from Day 1 to Day 7.
  • Placebo Comparator: 004
    Placebo matching canagliflozin placebo once daily for 7 consecutive days from Day 1 to Day 7

Primary Outcome Measure

The concentration of canagliflozin and major metabolites (M5 and M7) in blood will be measured by protocol-specified pharmacokinetic parameters. [ Time Frame: At protocol-specified time points through Day 7 ]

Locations (2)

FacilityCityStateZIPSite coordinators
-Fort MyersFlorida--
-MiramarFlorida--

Find similar trials in Fort Myers, FL

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss

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