A Study to Assess Electrocardiogram Results in Healthy Volunteers Receiving Canagliflozin (JNJ-28431754)
Completed · Phase 1 · Has a placebo group
Conditions studied: Healthy
In brief
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.
Key facts
- Study ID
- NCT01787357
- Run by
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- People needed
- 60
- Starts
- 2008-06-01
- Expected to finish
- 2008-09-01
- Last updated by the study team
- 2016-06-29
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Study site — Tempe, Arizona, United States
Full record on ClinicalTrials.gov
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