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

Healthy Volunteer Clinical Trial

Official title:

The Effect of Hepatic Impairment on the Pharmacokinetics of RO5190591/Ritonavir: A Multiple-Center, Open-Label Study Following Multiple Oral Doses of RO5190591/Ritonavir to Subjects With Mild, Moderate, or Severe Hepatic Impairment and Healthy Subjects With Normal Hepatic Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01185873
• Other study ID #: NP25290
• Secondary ID: 2010-020314-29
• Status: Completed
• Phase: Phase 1
• First received: August 17, 2010
• Last updated: November 1, 2016
• Start date: February 2011
• Est. completion date: December 2013

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• danoprevir
Repeated oral doses
• ritonavir
Repeated oral doses

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Czech Republic,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (plasma concentration) of danoprevir in patients with hepatic impairment		From baseline to day 10	No
Secondary	Safety and tolerability (incidence of adverse events) of danoprevir in patients with hepatic impairment		From baseline to day 10	No