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

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ClinicalTrials.gov Identifier: NCT01185873
Recruitment Status : Completed
First Posted : August 20, 2010
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
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 : February 2011
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Ritonavir

Arm Intervention/treatment
Experimental: 1 Drug: danoprevir
Repeated oral doses

Drug: ritonavir
Repeated oral doses




Primary Outcome Measures :
  1. Pharmacokinetics (plasma concentration) of danoprevir in patients with hepatic impairment [ Time Frame: From baseline to day 10 ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01185873


Locations
United States, Kansas
Lenexa, Kansas, United States, 66219
Czech Republic
Prague 8, Czech Republic, 180 00
Praha 7, Czech Republic, 170 00
Slovakia
Bratislava, Slovakia, 831 01
Bratislava, Slovakia, 83305
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01185873     History of Changes
Other Study ID Numbers: NP25290
2010-020314-29
First Posted: August 20, 2010    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Ritonavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors