drugset / Trial / NCT02422589
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
NaSingle-groupOpen-labelOther
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.
Timeline
- Start
- 2015-10-23
- Primary completion
- 2017-12-12
- Completion
- 2017-12-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ceritinib | Small molecule | — | — |
| Subject | Midazolam | Small molecule | — | — |
| Subject | Warfarin | Small molecule | — | — |
Indications
No indication recorded.