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A Study of RO5190591 (Danoprevir) in Healthy Volunteers

NCT01164488 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2016-08-29

No results posted yet for this study

Summary

This non-randomized, open-label study will evaluate the interaction of RO5190591(danoprevir)/ritonavir with and without ketoconazole and the safety and tolerability in healthy volunteers. Participants will be administered repeated daily doses of ketoconazole alone, RO5190591/ritonavir, and RO5190591/ritonavir plus ketoconazole. The anticipated time on study treatment is 25 days.

Conditions

  • Healthy Volunteer

Interventions

DRUG

danoprevir

Repeated daily doses

DRUG

ketoconazole

Repeated daily doses

DRUG

ritonavir

Repeated daily 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
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2010-08-31
Completion
2010-08-31

Countries

  • United States

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 NCT01164488 on ClinicalTrials.gov