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NCT01588002 · ClinicalTrials.gov registry record · Phase 1
A Study of Potential Drug-Drug Interaction Between Efavirenz and Danoprevir 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
NCT01588002: Completed Phase 1 study, sponsored by Hoffmann-La Roche.
NCT01588002 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
NCT01588002, 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 phase 1, randomized, open-label, multiple-dose, 2-sequence, 2-period crossover study will evaluate potential drug-drug interaction between efavirenz and danoprevir with low-dose ritonavir in healthy volunteers. In Period 1. subjects will be randomized to receive multiple oral doses of either danoprevir with ritonavir or efavirenz for 14 days. In Period 2, all subjects will receive multiple oral doses of the combination danoprevir with ritonavir and efavirenz for 14 days. Anticipated time on study treatment is 28 days.
Interventions
- DRUG ritonavir
- DRUG efavirenz
- DRUG danoprevir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2012-04 |
| Est. Completion | 2012-06 |
| Phase | Phase 1 |
What the finished NCT01588002 record still lists
NCT01588002 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.
NCT01588002 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01588002 about?
NCT01588002 is a clinical study titled "A Study of Potential Drug-Drug Interaction Between Efavirenz and Danoprevir With Low Dose Ritonavir in Healthy Volunteers". This phase 1, randomized, open-label, multiple-dose, 2-sequence, 2-period crossover study will evaluate potential drug-drug interaction between efavirenz and danoprevir with low-dose ritonavir in healthy volunteers. In Period 1. subjects will be randomized to receive multiple oral doses of either da...
What is the current status of trial NCT01588002?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2012-04. Estimated completion is 2012-06.
What interventions are being tested in trial NCT01588002?
The interventions under investigation include: ritonavir (DRUG), efavirenz (DRUG), danoprevir (DRUG).
Who is sponsoring clinical trial NCT01588002?
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 NCT01588002'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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