Status:
COMPLETED
A Study of Danoprevir in Healthy Volunteers And Patients With Hepatic Impairment
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Healthy Volunteer
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
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 m...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT01185873
Start Date
February 1 2011
End Date
December 1 2013
Last Update
November 2 2016
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Lenexa, Kansas, United States, 66219
2
Prague, Czechia, 170 00
3
Prague, Czechia, 180 00
4
Bratislava, Slovakia, 831 01