- 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 approximately 17.5 kg/m2 to 30.5 kg/m2 and a total body
weight > 50 kg (110 lbs).
- An informed consent document signed and dated by the subject or a legally acceptable
- Subjects who are willing and able to comply with scheduled visits, treatment plan,
laboratory tests, and other study procedures.
- Subjects who have urinary LTE4 levels greater than or equal to 30 pg/mg Creatinine at
screening following spot urinary collection for Cohort 2.
- 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).
- Any condition possibly affecting drug absorption (eg, gastrectomy).
- A positive urine drug screen.