- Healthy male and/or female subjects of non-childbearing potential between the ages of
18 years of age to abnormalities identified by a detailed medical history, full physical examination,
including blood pressure and pulse rate measurement, 12-lead ECG and clinical
laboratory tests. Liver function tests, albumin and prothrombin time must be within
- Body Mass Index (BMI) of 18 to 35 kg/m2;
- 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.
- Subjects in the normal hepatic function group (Group 1): No known or suspected hepatic
- For subjects in the hepatic impairment groups (Groups 2 and 3):
- Should satisfy the criteria for Class A or B of the modified Child-Pugh
- A diagnosis of hepatic dysfunction due to hepatocellular disease (and not
secondary to any acute ongoing hepatocellular process) documented by medical
history, physical examination, liver biopsy, hepatic ultrasound, CT scan, or MRI.
- Stable hepatic impairment, defined as no clinically significant change in disease
status within the last 30 days, as documented by the subject's recent medical
- Must be on a stable dose of medication and/or treatment regimen.
- Any condition possibly affecting drug absorption (eg, gastrectomy, chronic diarrhea,
- A positive urine drug screen.
- Females of childbearing potential, including those with tubal ligation. [To be
considered for enrollment, women of at least 45 years of age who are postmenopausal
(defined as being amenorrheic for at least 2 years) must have confirmatory FSH test
results at screening].
- In addition, subjects in the hepatic impairment groups (Groups 2 and 3) presenting
with any of the following will not be included in the trial:
- Hepatic carcinoma and hepatorenal syndrome or life expectancy
- Undergone porta-caval shunt surgery.
- History of gastrointestinal hemorrhage due to esophageal varices or peptic ulcers
less than one month prior to study entry.