Healthy Volunteer
Conditions
Brief summary
This non-randomized, multi-center, open-label study will evaluate the pharmacokinetics and the safety and tolerability of danoprevir (RO5190591) and ritonavir in healthy volunteers and patients with mild, moderate or severe hepatic impairment. Participants will be administered repeated daily doses of danoprevir and ritonavir. The anticipated time on study treatment is 10 days.
Interventions
DRUGdanoprevir
Repeated oral doses
DRUGritonavir
Repeated oral doses
Sponsors
Hoffmann-La Roche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (plasma concentration) of danoprevir in patients with hepatic impairment | From baseline to day 10 |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability (incidence of adverse events) of danoprevir in patients with hepatic impairment | From baseline to day 10 |
Countries
Czechia, Slovakia, United States
Outcome results
None listed