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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: Completed Phase 1 study, sponsored by Hoffmann-La Roche.
NCT01514968 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT01514968 record still lists
NCT01514968 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 3 interventions - of which ritonavir is the first listed.
NCT01514968 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01514968's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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