A Pharmacokinetic and Pharmacodynamic Study to Determine Blood Levels of JNJ-28431754 (Canagliflozin) in Patients With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    

Detailed description: 
      Canagliflozin is a drug that is being tested to see if it may be useful in treating patients
      diagnosed with type 2 diabetes mellitus (T2DM). This is a randomized (patients will assigned
      to 1 of 4 study treatments by chance), double-blind (neither the patient or the study doctor
      will know the name of the assigned treatment), study to assess the pharmacokinetics (blood
      levels) and pharmacodynamics (effects of the drug on the body) of canagliflozin compared to a
      placebo (a capsule that looks like all the other treatments but has no real medicine) in
      patients with T2DM. Approximately 36 patients with T2DM will receive once-daily treatment
      with canagliflozin (50 mg, 100 mg, or 300 mg doses) or placebo for 7 days. Patients will
      participate in the study for approximately 9 weeks. Blood and urine samples will be collected
      at specified times before and after each dose of study drug for pharmacokinetic and
      pharmacodynamic analyses. A blood sample will also be collected before the first dose of
      study drug for pharmacogenomic analysis (ie, genetic testing) for possible use in
      characterizing the safety and/or efficacy of study drug in relation to the patient
      pharmacogenic profile. During the study, the safety and tolerability of canagliflozin will be
      evaluated by monitoring adverse events and findings from laboratory evaluations, vital signs
      measurements, and ECG measurements. The primary outcome measure in the study is the
      concentration of canagliflozin and its major metabolites (M5 and M7) in the blood measured by
      protocol-specified pharmacokinetic parameters at protocol specified time points through Day
      7. Study drug will be taken orally (by mouth) once daily before the first meal each day. On
      Day -1, patients will take 1 dose of placebo in single-blind fashion (patient blinded) to
      determine baseline assessments. After randomization, patients will take single doses of
      double-blind canagliflozin (50 mg, 100 mg, or 300 mg) or matching placebo once daily for 7
      days (Day 1 through Day 7).
    

Intervention name(s): Canagliflozin 50 mg; Canagliflozin 100 mg; Canagliflozin 300 mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 50 mg capsule once daily for 7 consecutive days from Day 1 to Day 7; 100 mg capsule once daily for 7 consecutive days from Day 1 to Day 7; 300 mg capsule once daily for 7 consecutive days from Day 1 to Day 7.; matching canagliflozin placebo once daily for 7 consecutive days from Day 1 to Day 7
Intervention MeSH terms: Canagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Canagliflozin; Placebo; Type 2 diabetes mellitus; Pharmacokinetic; Pharmacodynamic