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NCT02365506 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Effect of Eleclazine on QT, Safety, and Tolerability in Participants With Long QT2 Syndrome
A Phase 1 study of LQT2 Syndrome, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
- 1
- Study location
NCT02365506: Completed Phase 1 study of LQT2 Syndrome, sponsored by Gilead Sciences.
NCT02365506 is a Phase 1 study of LQT2 Syndrome that has completed, run by Gilead Sciences. The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02365506, a Phase 1 study of LQT2 Syndrome, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary objective of the study is to evaluate the effect of oral eleclazine (formerly GS-6615) on corrected QT (QTc) interval in participants with long QT2 syndrome.
Primary Outcome
Daytime (AUC0-8)/8 was defined as the area under the QTc curve during the 8 hours postdose, where 0 was defined as the time of dosing (i.e., T = 0) on a given day. Daytime (AUC0-8)/8 was computed by dividing AUC0-8 by the time from dosing to the 8 hour postdose time point. QTcF is corrected QT interval using Fridericia's formula.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Eleclazine
Study Locations (1)
New York
- University of Rochester Medical Center/Strong Memorial Hospital - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2015-07-20 |
| Est. Completion | 2016-06-13 |
| Phase | Phase 1 |
What the finished NCT02365506 record still lists
NCT02365506 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).
The record links to 1 condition, with LQT2 Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02365506 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT02365506 about?
NCT02365506 is a clinical study titled "Study to Evaluate the Effect of Eleclazine on QT, Safety, and Tolerability in Participants With Long QT2 Syndrome". The primary objective of the study is to evaluate the effect of oral eleclazine (formerly GS-6615) on corrected QT (QTc) interval in participants with long QT2 syndrome.
What is the current status of trial NCT02365506?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2015-07-20. Estimated completion is 2016-06-13.
What conditions does trial NCT02365506 study?
This clinical trial studies the following conditions: LQT2 Syndrome.
What interventions are being tested in trial NCT02365506?
The interventions under investigation include: Placebo (DRUG), Eleclazine (DRUG).
Who is sponsoring clinical trial NCT02365506?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02365506 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02365506's enrollment target sits among peer trials
13 1847th of 2000 higher than 149 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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