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

• Sponsor: Hoffmann-La Roche (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01185873
• Collaborator: (none)
• Enrollment: 81
• Locations: 5
• Arm: 1
• Duration (Months): 34
• Patients Per Site: 16.2
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteer	Drug: danoprevir; Drug: ritonavir	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 81 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Feb 1, 2011
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: danoprevir; Repeated oral doses; Drug: ritonavir; Repeated oral doses

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetics (plasma concentration) of danoprevir in patients with hepatic impairment [From baseline to day 10]

Secondary Outcome Measures

1. Safety and tolerability (incidence of adverse events) of danoprevir in patients with hepatic impairment [From baseline to day 10]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Lenexa	Kansas	United States	66219
2		Prague 8		Czech Republic	180 00
3		Praha 7		Czech Republic	170 00
4		Bratislava		Slovakia	831 01
5		Bratislava		Slovakia	83305

Sponsors and Collaborators

• Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT01185873
• Other Study ID Numbers: NP25290; 2010-020314-29
• First Posted: Aug 20, 2010
• Last Update Posted: Nov 2, 2016
• Last Verified: Nov 1, 2016

• Additional relevant MeSH terms: Ritonavir

Study Results

No Results Posted as of Nov 2, 2016