- Healthy Chinese volunteers (individuals currently residing in mainland China, who
were born in China, and whose parents are both of Chinese descent).
- Healthy male and/or female (of non-childbearing potential) subjects between the ages
of 18 and 45 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).
- Body Mass Index (BMI) of 19.0 to 24.0 kg/m2; and a total body weight should be 50 kg
(110 lbs).
- Evidence or history of clinically significant dermatologic, hematological, renal,
endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric,
neurologic, or allergic disease (including drug allergies, but excluding untreated,
asymptomatic, seasonal allergies at the time of dosing).
- Any condition possibly affecting drug absorption (eg, gastrectomy).
- Drug dependency, a positive urine drug screen and/or alcohol dependency.
- Use of tobacco- or nicotine- containing products (or a positive urine cotinine test).
- History of regular alcohol consumption exceeding 7 drinks/week for females or 14
drinks/week for men (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of
beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
- Treatment with an investigational drug or biologic within the last 3 months (or as
determined by the local requirement) or 5 half-lives preceding the first dose of
study medication, whichever is longer.