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NCT02422589 · ClinicalTrials.gov registry record · Phase 1
A Phase I, Multi-center, Open Label, Drug-drug Interaction Study to Assess the Effect of Ceritinib on the Pharmacokinetics of Warfarin and Midazolam in Patients With ALK-positive Advanced Tumors
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 33
- Enrollment target
NCT02422589: Completed Phase 1 study, sponsored by Novartis Pharmaceuticals.
NCT02422589 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 33 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02422589, a Phase 1 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 33 participants
- Enrollment target
Study Summary
The purpose of this study was to evaluate the potential inhibitory effects of ceritinib on the CYP3A4- and CYP2C9-mediated metabolism of the probe drugs midazolam and warfarin, respectively, when administered simultaneously as a cocktail. The results obtained from this drug interaction study would provide guidance that would enable an update to the ceritinib labeling and ouldl help guide recommendations for administration of co-medications in future clinical trials.
Interventions
- DRUG midazolam
- DRUG ceritinib
- DRUG warfarin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2015-10-23 |
| Est. Completion | 2017-12-12 |
| Phase | Phase 1 |
What the finished NCT02422589 record still lists
NCT02422589 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower).
The record links to 0 conditions, and to 3 interventions - of which midazolam is the first listed.
NCT02422589 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02422589 about?
NCT02422589 is a clinical study titled "A Phase I, Multi-center, Open Label, Drug-drug Interaction Study to Assess the Effect of Ceritinib on the Pharmacokinetics of Warfarin and Midazolam in Patients With ALK-positive Advanced Tumors". The purpose of this study was to evaluate the potential inhibitory effects of ceritinib on the CYP3A4- and CYP2C9-mediated metabolism of the probe drugs midazolam and warfarin, respectively, when administered simultaneously as a cocktail. The results obtained from this drug interaction study would p...
What is the current status of trial NCT02422589?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2015-10-23. Estimated completion is 2017-12-12.
What interventions are being tested in trial NCT02422589?
The interventions under investigation include: midazolam (DRUG), ceritinib (DRUG), warfarin (DRUG).
Who is sponsoring clinical trial NCT02422589?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02422589's enrollment target sits among peer trials
33 1280th of 2000 higher than 705 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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