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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
52
ISIS 304801 is supplied as 200mg of volanesorsen with 1.0mL of solution per vial
Moxifloxacin Hydrochloride 400 mg tablet administered orally, Single Dose
Covance
Dallas, Texas, United States
Placebo corrected change from baseline in QTcF (corrected Frederica's CT Interval)
ECG monitoring up to 24 hours post dose
Time frame: 24 Hours
Placebo corrected change from baseline heart rate (HR, PR and QRS)
ECG monitoring 24 hours post dose
Time frame: 24 Hours
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