- Healthy male and/or female subjects (Healthy is defined as no clinically relevant
abnormalities identified by a detailed medical history except drug abuse), full
physical examination, including blood pressure and pulse rate measurement, 12-lead
ECG and clinical laboratory tests).
- Body Mass Index (BMI) of 17.5 to 35.5 kg/m2; and a total body weight >50 kg (110
- Receiving stable methadone maintenance treatment for at least 3 months (dose range
50-150 mg QD).
- Subjects on therapy for Hepatitis B and/or Hepatitis C; Evidence of impaired liver
function (ie, AST and/or ALT greater than 3 times the upper limit of normal, total
bilirubin >1.5 times the upper limit of normal, albumin
- 12-lead ECG demonstrating QTc >450 msec for males and QTc >470 msec for females or
any other clinically significant abnormalities at screening.