A Study to Assess Electrocardiogram Results in Healthy Volunteers Receiving Canagliflozin (JNJ-28431754)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effect of canagliflozin (JNJ-28431754) on
      electrocardiogram results (recordings of the electrical activity of the heart) in healthy
      volunteers after a single therapeutic dose (300 mg) and a single supra-therapeutic dose (4
      times higher [1,200 mg] than the anticipated therapeutic dose of 300 mg). The safety and
      tolerability of canagliflozin will also be assessed.
    

Detailed description: 
      This study will be a randomized (the treatment is assigned by chance), single-center,
      double-blind (neither investigator nor volunteer knows the identity of the assigned
      treatment), double-dummy (a technique for retaining the blinded nature of the study when the
      treatments do not look identical), placebo-controlled (one of the treatments is inactive),
      positive-controlled (one of the treatments has a known potential effect on electrocardiogram
      results), four-way cross-over study (all volunteers will receive each of the 4 treatments but
      in a different order) to assess the effect of canagliflozin (a drug currently being
      investigated for the treatment of type 2 diabetes mellitus) on electrocardiogram results in
      healthy volunteers. The study will consist of 3 phases: a screening phase, a double-blind
      treatment phase, and an end-of study (or follow-up) phase. Volunteers will be assigned to 1
      of 4 treatment sequence groups (ADBC, DABC, BCDA, or CDAB). The treatment sequence will be
      decided by randomization. Treatment A will be a single dose of 300 mg of canagliflozin.
      Treatment B will be a single dose of 1,200 mg of canagliflozin. Treatment C will be a single
      dose of placebo (inactive medication). Treatment D will be a single dose of 400 mg of
      moxifloxacin (an antibiotic with known potential to affect electrocardiogram results). Each
      treatment will be given during a treatment period of 2 days duration; each treatment period
      will be separated by a washout period (when no medication is given) of 10 to 14 days. Each
      volunteer will participate in the study for approximately 61 days.
    

Intervention name(s): Canagliflozin (JNJ-28431754); Placebo; Moxifloxacin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): One 300 mg dose of canagliflozin (JNJ-28431754) (comprising one 100 mg over-encapsulated tablet and one 200 mg over-encapsulated tablet) taken orally (by mouth) on Day 1 of Treatment A. One 1,200 mg dose of canagliflozin (comprising six 200 mg over-encapsulated tablets) taken orally on Day 1 of Treatment B.; Four over-encapsulated matching placebo tablets taken orally (by mouth) on Day 1 of Treatment A. Six over-encapsulated matching placebo tablets taken orally on Day 1 of Treatment C. Five encapsulated matching placebo tablets taken orally on Day 1 of Treatment D.; One 400 mg over-encapsulated tablet of moxifloxacin taken orally (by mouth) on Day 1 of Treatment D.
Other intervention name(s): JNJ-28431754
Intervention MeSH terms: Canagliflozin; Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Healthy; Canagliflozin (JNJ-28431754); Pharmacokinetics; Moxifloxacin; Electrocardiogram Parameters; QT/QTc Interval; Therapeutic dose; Supra-Therapeutic dose