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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 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.
Details
| Lead sponsor | Novartis Pharmaceuticals |
|---|---|
| Phase | PHASE1 |
| Status | COMPLETED |
| Enrolment | 33 |
| Start date | Fri Oct 23 2015 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Tue Dec 12 2017 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- ALK-positive Advanced Tumors
Interventions
- ceritinib
- warfarin
- midazolam
Countries
Denmark, United States, Spain, Italy