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NCT01514968 · ClinicalTrials.gov registry record · Phase 1
A Drug-Drug Interaction Study Between Danoprevir/Low-Dose Ritonavir and Cyclosporine in Healthy Volunteers
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT01514968 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 18 participants.
The verdict
NCT01514968, 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 single-dose, randomized, open-label, 2-sequence, 3-period study will evaluate the effect of cyclosporine on the pharmacokinetics of ritonavir-boosted danoprevir (DNV/r) in healthy volunteers. Subjects will be randomized to one of two treatment sequences to receive a single oral dose of DNV/r or cyclosporine. In treatment period 3, subjects will receive a single oral dose of DNV/r plus cyclosporine. Anticipated time on study is 33 days.
Interventions
- DRUG ritonavir
- DRUG cyclosporine
- DRUG danoprevir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2011-12 |
| Est. Completion | 2012-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01514968
The ClinicalTrials.gov registry entry for NCT01514968 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.
NCT01514968 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01514968 about?
NCT01514968 is a clinical study titled "A Drug-Drug Interaction Study Between Danoprevir/Low-Dose Ritonavir and Cyclosporine in Healthy Volunteers". This single-dose, randomized, open-label, 2-sequence, 3-period study will evaluate the effect of cyclosporine on the pharmacokinetics of ritonavir-boosted danoprevir (DNV/r) in healthy volunteers. Subjects will be randomized to one of two treatment sequences to receive a single oral dose of DNV/r or...
What is the current status of trial NCT01514968?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2011-12. Estimated completion is 2012-02.
What interventions are being tested in trial NCT01514968?
The interventions under investigation include: ritonavir (DRUG), cyclosporine (DRUG), danoprevir (DRUG).
Who is sponsoring clinical trial NCT01514968?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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