An Open Label Phase 1 Study To Evaluate The Pharmacokinetics Of AG-013736 In Healthy Chinese Volunteers
- Healthy male and/or female (of nonchildbearing potential) Chinese (individuals
currently residing in mainland China who were born in China and have both parents of
Chinese descent) 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 and clinical laboratory tests.)
- Body Mass Index (BMI) of 19 to 24 kg/m2; and a total body weight >50 kg (110 lbs). A
BMI lower limit of 18.5 kg/m2 may be rounded up to 19.0 kg/m2; a BMI upper limit of
24.5 kg/m2 may be rounded down to 24.0 kg/m2 and will be acceptable for inclusion.
- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal
allergies at time of dosing) disease or clinical findings at Screening.
- Any condition possibly affecting drug absorption (eg, gastrectomy).
- Drug dependency, a positive urine drug screen, or alcohol dependency.
- History of regular alcohol consumption exceeding 28 or more units per week. (One
unit=285 mL of beer or 25 mL of spirits or 125 mL of wine).
- Use of tobacco- or nicotine-containing products (or a positive urine cotinine test).
- Treatment with an investigational drug within 3 months (or as determined by local
regulations) or 5 half-lives preceding the first dose of study medication.