Overview

A Pharmacokinetics (PK) Study of the Effects Rabeprazole and Rifampin on Dabrafenib in Subjects With BRAF V600 Mutation Positive Tumors

Status:
Completed

Trial end date:
2016-02-29

Target enrollment:

Participant gender:

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.

Phase:

Phase 1

Details

Lead Sponsor:

GlaxoSmithKline

Treatments:

Dabrafenib
Rabeprazole
Rifampin