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NCT01787357 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess Electrocardiogram Results in Healthy Volunteers Receiving Canagliflozin (JNJ-28431754)
A Phase 1 study, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT01787357: Completed Phase 1 study, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
NCT01787357 is a Phase 1 study that has completed, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01787357, a Phase 1 study, has completed, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study 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.
Primary Outcome
QT intervals (assessment of the electrical activity of the heart) will be measured from 12-lead electrocardiogram (ECG) readings and will be corrected for heart rate. The corrected QT intervals (QTc) obtained following single doses of 300 mg canagliflozin (JNJ-28431754), 1,200 mg canagliflozin, and 400 mg moxifloxacin, will be compared with QTc intervals obtained following dosing with placebo.
Interventions
- DRUG Placebo
- DRUG Moxifloxacin
- DRUG Canagliflozin (JNJ-28431754)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2008-06 |
| Est. Completion | 2008-09 |
| Phase | Phase 1 |
What the finished NCT01787357 record still lists
NCT01787357 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01787357 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01787357 about?
NCT01787357 is a clinical study titled "A Study to Assess Electrocardiogram Results in Healthy Volunteers Receiving Canagliflozin (JNJ-28431754)". 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...
What is the current status of trial NCT01787357?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2008-06. Estimated completion is 2008-09.
What interventions are being tested in trial NCT01787357?
The interventions under investigation include: Placebo (DRUG), Moxifloxacin (DRUG), Canagliflozin (JNJ-28431754) (DRUG).
Who is sponsoring clinical trial NCT01787357?
This trial is sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C., which has 102 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01787357's enrollment target sits among peer trials
60 831st of 2000 higher than 1,106 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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