- Healthy males and/or females of non-childbearing potential between the ages of 18 (or
21 based on country-specific age of consent) and 60 years, inclusive, at Screening.
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/safety laboratory tests.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2 inclusive; and a total body weight >50 kg
- Use of CYP3A4 inhibitors (eg, ketoconazole, ciprofloxacin, diltiazem) or inducers (eg,
pheytoin, carbamazepine) or substrate (eg, simvastatin, quinidine) within 28 days or 5
half-lives (whichever is longer) prior to Day 1.
- Known history of hypersensitivity, allergy, severe adverse drug reaction or
intolerance to simvastatin or other statins.