ABOUT THIS STUDY
- -A positive urine drug test.
- Screening supine 12-lead ECG demonstrating a corrected QT (QTc) interval >450 msec or
a QRS interval >120 msec. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG
should be repeated 2 more times and the average of the 3 QTc or QRS values should be
used to determine the subject's eligibility.
- Subjects with family history of myocardial infarction, congenital long QT syndrome,
torsades de pointes or clinically significant ventricular arrhythmias. Subjects should
be within normal range of potassium, magnesium and corrected calcium calculation at
- Pregnant female subjects; breastfeeding female subjects; female subjects of
childbearing potential; male subjects with partners currently pregnant; male subjects
who are unwilling or unable to use two highly effective methods of contraception as
outlined in this protocol for the duration of the study and for at least 90 days after
the last dose of investigational product and, refrain from sperm donation for the
duration of the Study and for at least 90 days after the last dose of investigational
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- New Haven, Connecticut