drugset / Trial / NCT01954043
A Pharmacokinetics (PK) Study of the Effects Rabeprazole and Rifampin on Dabrafenib in Subjects With BRAF V600 Mutation Positive Tumors
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The study is being conducted to evaluate the effect of rifampin (a strong CYP3A4 inducer) and rabeprazole (a pH elevating agent) on the PK of dabrafenib (a CYP3A4/CYP2C8 substrate). The study will be conducted in subjects with BRAF V600 mutation-positive tumors. Data collected from this study will be used to inform recommendations regarding use of concomitant medications with dabrafenib and future clinical pharmacologic evaluation of dabrafenib.
Timeline
- Start
- 2013-12-20
- Primary completion
- 2016-02-29
- Completion
- 2016-02-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dabrafenib | Small molecule | 150 mg | — |
| Subject | Rabeprazole | Small molecule | 40 mg | — |
| Subject | Rifampin | Small molecule | 600 mg | — |