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

NCT01185873 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2016-11-02

No results posted yet for this study

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.

Conditions

  • Healthy Volunteer

Interventions

DRUG

danoprevir

Repeated oral doses

DRUG

ritonavir

Repeated oral doses

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • United States
  • Czechia
  • Slovakia

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01185873 on ClinicalTrials.gov