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NCT01591850 · ClinicalTrials.gov registry record · Phase 1
A Drug-Drug Interaction Study of Ketoconazole, Rifampicin and Ritonavir-Boosted Atazanavir With Single-Dose RO5093151 in Healthy Volunteers
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 51
- Enrollment target
NCT01591850: Completed Phase 1 study, sponsored by Hoffmann-La Roche.
NCT01591850 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 51 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01591850, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 51 participants
- Enrollment target
Study Summary
This randomized, single-center, open-label, one-sequence, two-period crossover study in three parts will assess the effects of multiple doses of ketoconazole, rifampicin and ritonavir-boosted atazanavir on the pharmacokinetics of a single dose of RO5093151 in healthy male and female volunteers. In Period 1, subjects will receive a single oral dose of RO5093151. In Period 2, subjects will receive a single oral dose of RO5093151 and multiple oral doses of either ketoconazole, rifampicin or ritonavir-boosted atazanavir. Anticipated time on study is up to 8.5 weeks.
Interventions
- DRUG ritonavir
- DRUG ketoconazole
- DRUG RO5093151
- DRUG atazanavir
- DRUG rifampicin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2011-09 |
| Est. Completion | 2011-11 |
| Phase | Phase 1 |
What the finished NCT01591850 record still lists
NCT01591850 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% lower).
The record links to 0 conditions, and to 5 interventions - of which ritonavir is the first listed.
NCT01591850 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01591850 about?
NCT01591850 is a clinical study titled "A Drug-Drug Interaction Study of Ketoconazole, Rifampicin and Ritonavir-Boosted Atazanavir With Single-Dose RO5093151 in Healthy Volunteers". This randomized, single-center, open-label, one-sequence, two-period crossover study in three parts will assess the effects of multiple doses of ketoconazole, rifampicin and ritonavir-boosted atazanavir on the pharmacokinetics of a single dose of RO5093151 in healthy male and female volunteers. In P...
What is the current status of trial NCT01591850?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 51 participants. The study started on 2011-09. Estimated completion is 2011-11.
What interventions are being tested in trial NCT01591850?
The interventions under investigation include: ritonavir (DRUG), ketoconazole (DRUG), RO5093151 (DRUG), atazanavir (DRUG), rifampicin (DRUG).
Who is sponsoring clinical trial NCT01591850?
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 NCT01591850's enrollment target sits among peer trials
51 969th of 2000 higher than 1,028 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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