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NCT01592305 · ClinicalTrials.gov registry record · Phase 1
A Study of Drug-Drug Interaction Between Danoprevir Coadministered With Low-Dose Ritonavir and Tenofovir Disoproxil Fumarate or Atazanavir
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT01592305 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 40 participants.
The verdict
NCT01592305, 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-treatment multiple-dose, 2-period, 2-sequence study will evaluate potential drug-drug interactions between danoprevir (DNV) when coadministered with low-dose ritonavir (r) and tenofovir disoproxil fumarate (TDF) or atazanavir (ATZ) in healthy volunteers. Subjects will be randomized to receive in Period 1 either single oral doses of TDF and multiple oral doses of DNV/r or multiple oral doses of ATZ/r. In Period 2, all subjects will receive multiple oral doses of DNV/r plus ATZ. Anticipated time on study treatment is up to 20 days.
Interventions
- DRUG ritonavir
- DRUG danoprevir
- DRUG atazanavir
- DRUG tenofovir disoproxil fumarate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2012-05 |
| Est. Completion | 2012-06 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01592305
The ClinicalTrials.gov registry entry for NCT01592305 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 40 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 4 interventions - of which ritonavir is the first listed.
NCT01592305 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01592305 about?
NCT01592305 is a clinical study titled "A Study of Drug-Drug Interaction Between Danoprevir Coadministered With Low-Dose Ritonavir and Tenofovir Disoproxil Fumarate or Atazanavir". This randomized, open-label, multiple-treatment multiple-dose, 2-period, 2-sequence study will evaluate potential drug-drug interactions between danoprevir (DNV) when coadministered with low-dose ritonavir (r) and tenofovir disoproxil fumarate (TDF) or atazanavir (ATZ) in healthy volunteers. Subject...
What is the current status of trial NCT01592305?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2012-05. Estimated completion is 2012-06.
What interventions are being tested in trial NCT01592305?
The interventions under investigation include: ritonavir (DRUG), danoprevir (DRUG), atazanavir (DRUG), tenofovir disoproxil fumarate (DRUG).
Who is sponsoring clinical trial NCT01592305?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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