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NCT02222324 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Effects of E2609 on QTc Interval in Healthy Subjects
A Phase 1 study, sponsored by Eisai.
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT02222324: Completed Phase 1 study, sponsored by Eisai.
NCT02222324 is a Phase 1 study that has completed, run by Eisai. 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
NCT02222324, a Phase 1 study, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study Summary
This thorough QT (TQT) study will take place in healthy subjects administered single doses of study drug. It will be a randomized, double-blind, placebo and active-controlled, 4-treatment crossover study. Subjects will be randomized in an equal ratio to one of 12 possible treatment sequences. Each treatment sequence will comprise all 4 treatments.
Primary Outcome
Holter recordings are taken from a portable device for continuously monitoring various electrical activity of the cardiovascular system for at least 24 hours. Baseline is defined as the mean of predose QTcF values obtained from ECGs extracted from Holter recordings before dosing during each treatment period.
Interventions
- DRUG Placebo
- DRUG Moxifloxacin
- DRUG E2609
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2014-08 |
| Est. Completion | 2014-12 |
| Phase | Phase 1 |
What the finished NCT02222324 record still lists
NCT02222324 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.
NCT02222324 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02222324 about?
NCT02222324 is a clinical study titled "A Study to Evaluate the Effects of E2609 on QTc Interval in Healthy Subjects". This thorough QT (TQT) study will take place in healthy subjects administered single doses of study drug. It will be a randomized, double-blind, placebo and active-controlled, 4-treatment crossover study. Subjects will be randomized in an equal ratio to one of 12 possible treatment sequences. Each t...
What is the current status of trial NCT02222324?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2014-08. Estimated completion is 2014-12.
What interventions are being tested in trial NCT02222324?
The interventions under investigation include: Placebo (DRUG), Moxifloxacin (DRUG), E2609 (DRUG).
Who is sponsoring clinical trial NCT02222324?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02222324'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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