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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 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 51 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01591850
The ClinicalTrials.gov registry entry for NCT01591850 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 51 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 5 interventions - of which ritonavir is the first listed.
NCT01591850 reports 0 study locations.
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.
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