ABOUT THIS STUDY
- Healthy male subjects 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 and clinical laboratory tests.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
- An informed consent document signed and dated by the subject.
- Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at time of dosing).
- Subjects enrolled in a previous radionucleotide study or who have received
radiotherapy within 12 months prior to screening or such that total radioactivity
would exceed acceptable dosimetry.
- A positive urine drug screen or urine cotinine test
- 12 lead ECG demonstrating QTc >450 or a QRS interval >120 msec msec at Screening. If
QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated two more
times and the average of the three QTc 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
calcium at screening.
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