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NCT01185873 · ClinicalTrials.gov registry record · Phase 1
A Study of Danoprevir in Healthy Volunteers And Patients With Hepatic Impairment
A Phase 1 study of Healthy Volunteer, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 81
- Enrollment target
- 5
- Study locations
NCT01185873 is a Phase 1 study of Healthy Volunteer that has completed, run by Hoffmann-La Roche. The registered enrollment target is 81 participants, below the 201-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (60% lower). The trial reports 5 study locations across 2 states.
The verdict
NCT01185873, a Phase 1 study of Healthy Volunteer, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 81 participants
- Enrollment target
- 5
- Study locations
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 Studied
Interventions
- DRUG ritonavir
- DRUG danoprevir
Study Locations (5)
Other
- - Prague
- - Prague
- - Bratislava
- - Bratislava
Kansas
- - Lenexa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2011-02 |
| Est. Completion | 2013-12 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01185873
The ClinicalTrials.gov registry entry for NCT01185873 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 81 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 201-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (60% lower). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Healthy Volunteer appearing as the primary indexed condition, and to 2 interventions - of which ritonavir is the first listed.
NCT01185873 reports 5 study locations spanning 2 distinct geographic areas - top geographies include Other, Kansas.
Frequently Asked Questions
What is clinical trial NCT01185873 about?
NCT01185873 is a clinical study titled "A Study of Danoprevir in Healthy Volunteers And Patients With Hepatic Impairment". 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 o...
What is the current status of trial NCT01185873?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 81 participants. The study started on 2011-02. Estimated completion is 2013-12.
What conditions does trial NCT01185873 study?
This clinical trial studies the following conditions: Healthy Volunteer.
What interventions are being tested in trial NCT01185873?
The interventions under investigation include: ritonavir (DRUG), danoprevir (DRUG).
Who is sponsoring clinical trial NCT01185873?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01185873 being conducted?
This trial has 5 study locations across Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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