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NCT02910635 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Effect of Volanesorsen on Cardiac Repolarization Conducted in Healthy Volunteers
A Phase 1 study of Abnormalities, Cardiovascular, sponsored by Ionis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
- 1
- Study location
NCT02910635: Completed Phase 1 study of Abnormalities, Cardiovascular, sponsored by Ionis Pharmaceuticals.
NCT02910635 is a Phase 1 study of Abnormalities, Cardiovascular that has completed, run by Ionis Pharmaceuticals. The registered enrollment target is 52 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02910635, a Phase 1 study of Abnormalities, Cardiovascular, has completed, sponsored by Ionis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 52 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary objective of this study is to assess the corrected QT interval (QTc) effect of volanesorsen (ISIS 304801) administered as a 300 mg subcutaneous (SC) therapeutic and a 300 mg intravenous (IV; 2-hour infusion) supra-therapeutic dose relative to placebo in healthy adult male and female subjects.
Primary Outcome
ECG monitoring up to 24 hours post dose
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Moxifloxacin
- DRUG Volanesorsen
Study Locations (1)
Texas
- Covance - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2016-09-19 |
| Est. Completion | 2016-12-20 |
| Phase | Phase 1 |
What the finished NCT02910635 record still lists
NCT02910635 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower).
The record links to 1 condition, with Abnormalities, Cardiovascular appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT02910635 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT02910635 about?
NCT02910635 is a clinical study titled "A Study to Evaluate the Effect of Volanesorsen on Cardiac Repolarization Conducted in Healthy Volunteers". The primary objective of this study is to assess the corrected QT interval (QTc) effect of volanesorsen (ISIS 304801) administered as a 300 mg subcutaneous (SC) therapeutic and a 300 mg intravenous (IV; 2-hour infusion) supra-therapeutic dose relative to placebo in healthy adult male and female subj...
What is the current status of trial NCT02910635?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2016-09-19. Estimated completion is 2016-12-20.
What conditions does trial NCT02910635 study?
This clinical trial studies the following conditions: Abnormalities, Cardiovascular.
What interventions are being tested in trial NCT02910635?
The interventions under investigation include: Placebo (DRUG), Moxifloxacin (DRUG), Volanesorsen (DRUG).
Who is sponsoring clinical trial NCT02910635?
This trial is sponsored by Ionis Pharmaceuticals, which has 76 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02910635 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02910635's enrollment target sits among peer trials
52 956th of 2000 higher than 1,032 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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