A Study of Danoprevir in Healthy Volunteers And Patients With Hepatic Impairment

Inclusion criteria

Healthy Volunteers:

• Adult healthy volunteers, 18-70 years of age
• Weight >/=50.0 kg
• Body Mass Index (BMI) 18.0-40.0 kg/m2
• Ability and willingness to abstain from alcohol-containing beverages or food from 48 hours prior to entry in the clinical study center until discharge
• Ability and willingness to abstain from grapefruit or grapefruit juice, star fruit, and Seville oranges from 7 days prior to entry in the clinical study center until discharge
• Medical history without major recent or ongoing pathology

Patients with hepatic impairment:

• Adult patients, 18-70 years of age
• Weight >/=50.0 kg
• Body Mass Index (BMI) 18.0-40.0 kg/m2
• Ability and willingness to abstain from alcohol-containing beverages or food from 48 hours prior to entry in the clinical study center until discharge
• Ability and willingness to abstain from grapefruit or grapefruit juice, star fruit, and Seville oranges from 7 days prior to entry in the clinical study center until discharge
• Stable, mild, moderate, or severe liver disease of cryptogenic, post-hepatic, hepatitis B or alcoholic origin

Exclusion criteria

Healthy Volunteers:

• Pregnant or lactating women and male partners of women who are pregnant or lactating
• Uncontrolled treated/untreated hypertension (systolic blood pressure >/=160 mmHg and /or diastolic blood pressure >/=105 mmHg
• Any history of clinically significant cardiovascular or cerebrovascular disease
• Creatinine clearance </=60 mL/min
• Positive test results for drugs or alcohol
• Donation or loss of blood over 450 ml within 60 days prior to screening

Patients with hepatic impairment:

• Pregnant or lactating women and male partners of women who are pregnant or lactating
• Uncontrolled treated/untreated hypertension (systolic blood pressure >/=160 mmHg and /or diastolic blood pressure >/=105 mmHg
• Any history of clinically significant cardiovascular or cerebrovascular disease
• Severe ascites at screening or admission to the clinic
• History of or current severe hepatic encephalopathy (grade 3 or higher)
• Any evidence of progressive liver disease within the last 4 weeks
• History of liver transplantation
• Creatinine clearance </=60 mL/min
• Positive test results for drugs or alcohol
• Donation or loss of blood over 450 ml within 60 days prior to screening