ABOUT THIS STUDY
- Healthy male and/or female subjects of non-childbearing potential, between the ages of 18 and 55 years, inclusive
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
- Japanese subjects must have four Japanese grandparents who were born in Japan.
- Mean body weight and the body weight range of Western subjects are similar to those of Japanese subjects with a 10% plus and minus error.
- An informed consent document signed and dated by the subject.
- Subjects who are willing and able to comply with scheduled visits, treatment plan,laboratory tests, and other study procedures.
- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
- Asian or Polynesian subjects in Western subject groups.
- Any condition possibly affecting drug absorption (eg, gastrectomy).
- A positive urine drug screen.
- History of regular alcohol consumption exceeding 7 drinks/week for females or 14
drinks/week for males within 6 months of screening.
- History or evidence of habitual use of tobacco or nicotine containing products within
3 months of Screening, with the exception of light smoking (up to 5 cigarettes per day
or the equivalent).
- Treatment with an investigational drug within 30 days or 5 half-lives preceding the
first dose of study medication.
- 12-lead ECG demonstrating QTc >450 msec at screening.
- Subjects with ANY of the following abnormalities on safety laboratory tests):
- Evidence of glycosuria, as defined by a positive urine dipstick test;
- Fasting serum triglyceride >300 mg/dL;
- Fasting LDL-cholesterol > than or equal to 190 mg/dL.
- Fasting serum glucose >125 mg/dL.
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- Hachioji, Tokyo