- 1. Healthy male and/or female subjects of non child bearing potential who, at the
time of screening, are between the ages of 18 and 55 years, inclusive. Healthy is
defined as no clinically relevant abnormalities identified by a detailed medical
history, full physical examination, including blood pressure and pulse rate
measurement, 12 lead ECG or clinical laboratory tests.
Female subjects of nonchildbearing potential must meet at least 1 of the following
1. Achieved postmenopausal status, defined as follows: cessation of regular menses for
at least 12 consecutive months with no alternative pathological or physiological
cause; with a serum follicle stimulating hormone (FSH) level confirming the
2. Have undergone a documented hysterectomy and/or bilateral oophorectomy;
3. Have medically confirmed ovarian failure. All other female subjects (including
females with tubal ligations and females that do NOT have a documented hysterectomy,
bilateral oophorectomy and/or ovarian failure) are considered to be of childbearing
2. Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110
3. Evidence of a personally signed and dated informed consent document indicating
that the subject has been informed of all pertinent aspects of the study.
4. Subjects who are willing and able to comply with all scheduled visits, treatment
plan, laboratory tests, and other study procedures.
- 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 screening.
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 atleast one 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 product.
History of known QTc prolongation or ECG abnormalities.
Self-reported history of risk factors for QT prolongation or torsades de pointes (eg,
organic heart disease, congestive heart failure, hypokalemia,
hypomagnesemia,congenital long QT syndrome, myocardial ischemia or infarction,
congenital deafness, and family history of sudden death, or a family history of
congenital QT syndrome).
Self-reported history of sick sinus syndrome, first, second, or third degree
atrioventricular (AV) block, myocardial infarction, pulmonary congestion, cardiac
arrhythmia, prolonged QT interval or conduction abnormalities, or any other
clinically significant cardiovascular disease history.