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NCT01164488 · ClinicalTrials.gov registry record · Phase 1
A Study of RO5190591 (Danoprevir) in Healthy Volunteers
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT01164488 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 18 participants.
The verdict
NCT01164488, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
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.
Interventions
- DRUG ritonavir
- DRUG ketoconazole
- DRUG danoprevir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2010-07 |
| Est. Completion | 2010-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01164488
The ClinicalTrials.gov registry entry for NCT01164488 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which ritonavir is the first listed.
NCT01164488 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01164488 about?
NCT01164488 is a clinical study titled "A Study of RO5190591 (Danoprevir) in Healthy Volunteers". 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...
What is the current status of trial NCT01164488?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2010-07. Estimated completion is 2010-08.
What interventions are being tested in trial NCT01164488?
The interventions under investigation include: ritonavir (DRUG), ketoconazole (DRUG), danoprevir (DRUG).
Who is sponsoring clinical trial NCT01164488?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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