A Study to Assess Electrocardiogram Results in Healthy Volunteers Receiving Canagliflozin (JNJ-28431754)
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 6/30/2016 |
| Start Date: | June 2008 |
| End Date: | September 2008 |
A Randomized, Double-Blind, Double-Dummy, Placebo- and Positive-Controlled, Four-Way Crossover Study Evaluating ECG Intervals in Healthy Adults Receiving a Single, Oral Dose of JNJ-28431754 at Therapeutic and Supra-Therapeutic Doses
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.
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.
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.
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.
Inclusion Criteria:
- Volunteers must have a body mass index (BMI = weight in kg/height in m2) between 18
and 35 kg/m2 (inclusive) and body weight not less than 50 kg
- Volunteers must have an average of triplicate 12-lead electrocardiogram (ECG)
recordings, taken with a maximum of 2 minutes between recordings, consistent with
normal cardiac conduction and function, as specified by the protocol
- Volunteers must be non-smokers
Exclusion Criteria:
- History of or currently active illness considered to be clinically significant by the
Investigator or any other illness that the Investigator considers should exclude the
patient from the study or that could interfere with the interpretation of the study
results
- History of additional risk factors for the presence of a family history of Short QT
Syndrome, Long QT Syndrome, sudden unexplained death at a young age (<=40 years),
drowning or sudden infant death syndrome in a first degree relative (ie, biological
parent, sibling, or child)
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