A Study to Evaluate the Effect of Volanesorsen on Cardiac Repolarization

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Trial 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.

See also
	Status	Clinical Trial	Phase
	Terminated	`NCT00593541` - Development of New Software Capabilities for Use With Cardiovascular Magnetic Resonance Imaging	N/A

NCT number	NCT02910635
Study type	Interventional
Source	Ionis Pharmaceuticals, Inc.
Contact
Status	Completed
Phase	Phase 1
Start date	September 19, 2016
Completion date	December 20, 2016

A Study to Evaluate the Effect of Volanesorsen on Cardiac Repolarization Conducted in Healthy Volunteers

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms