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NCT01519336 · ClinicalTrials.gov registry record · Phase 1
A Study of Drug-Drug Interaction Between Darunavir and Danoprevir Administered Together With Low-Dose Ritonavir in Healthy Volunteers
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT01519336: Completed Phase 1 study, sponsored by Hoffmann-La Roche.
NCT01519336 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01519336, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
This randomized, open-label, multiple-dose, 2-period crossover study will evaluate potential drug-drug interactions between darunavir and danoprevir when administered together with low-dose ritonavir in healthy volunteers. In Period 1, subjects will be randomized to receive either darunavir or danoprevir together with low-dose ritonavir for 10 days. In Period 2, all subjects will receive darunavir plus danoprevir together with ritonavir for 10 days. Anticipated time on study treatment is 20 days.
Interventions
- DRUG ritonavir
- DRUG darunavir
- DRUG danoprevir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2012-02 |
| Est. Completion | 2012-03 |
| Phase | Phase 1 |
What the finished NCT01519336 record still lists
NCT01519336 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 3 interventions - of which ritonavir is the first listed.
NCT01519336 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01519336 about?
NCT01519336 is a clinical study titled "A Study of Drug-Drug Interaction Between Darunavir and Danoprevir Administered Together With Low-Dose Ritonavir in Healthy Volunteers". This randomized, open-label, multiple-dose, 2-period crossover study will evaluate potential drug-drug interactions between darunavir and danoprevir when administered together with low-dose ritonavir in healthy volunteers. In Period 1, subjects will be randomized to receive either darunavir or danop...
What is the current status of trial NCT01519336?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2012-02. Estimated completion is 2012-03.
What interventions are being tested in trial NCT01519336?
The interventions under investigation include: ritonavir (DRUG), darunavir (DRUG), danoprevir (DRUG).
Who is sponsoring clinical trial NCT01519336?
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 NCT01519336's enrollment target sits among peer trials
40 1130th of 2000 higher than 810 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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