- Healthy male subjects between the ages of 18 and 50 years inclusive (unless local
regulations dictate a minimum age of 21 years). 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 of between 50 kg
and 100 kg inclusive.
- Evidence of a personally signed and dated informed consent document indicating that
the subject (or a legally acceptable representative) has been informed of all
pertinent aspects of the trial.
- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, genitourinary, psychiatric, neurologic,
or allergic disease (including drug allergies, but excluding untreated, symptomatic,
seasonal allergies at time of dosing).
- Any condition possibly affecting drug absorption.
- 12-lead ECG demonstrating QTcF >450 msec at Screening. If QTcF exceeds 450 msec, the
ECG should be repeated two more times and the average of the three QTcF values should
be used to determine the subject's eligibility.