NCT01185873

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2011

Typical duration for phase_1

Geographic Reach
3 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 20, 2010

Completed
6 months until next milestone

Study Start

First participant enrolled

February 1, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

2.8 years

First QC Date

August 17, 2010

Last Update Submit

November 1, 2016

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics (plasma concentration) of danoprevir in patients with hepatic impairment

    From baseline to day 10

Secondary Outcomes (1)

  • Safety and tolerability (incidence of adverse events) of danoprevir in patients with hepatic impairment

    From baseline to day 10

Study Arms (1)

1

EXPERIMENTAL
Drug: danoprevirDrug: ritonavir

Interventions

danoprevirDRUG

Repeated oral doses

1
ritonavirDRUG

Repeated oral doses

1

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Unknown Facility

Lenexa, Kansas, 66219, United States

Location

Unknown Facility

Prague, 170 00, Czechia

Location

Unknown Facility

Prague, 180 00, Czechia

Location

Unknown Facility

Bratislava, 831 01, Slovakia

Location

Unknown Facility

Bratislava, 83305, Slovakia

Location

MeSH Terms

Interventions

danoprevirRitonavir

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2010

First Posted

August 20, 2010

Study Start

February 1, 2011

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

CZ(2)SL(2)US(1)