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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 is a Phase 1 study of Abnormalities, Cardiovascular that has completed, run by Ionis Pharmaceuticals. The registered enrollment target is 52 participants. The trial reports 1 study location across 1 state.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02910635
The ClinicalTrials.gov registry entry for NCT02910635 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ionis Pharmaceuticals, which has 76 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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