An Open Label Study to Examine the Effects of a High-Fat Meal and Particle Size on the Pharmacokinetics of Orally Administered GSK2118436 in Subjects With BRAF Mutation Positive Tumor

Summary

The study is designed to evaluate the effects of a high fat meal on the pharmacokinetics of 150 mg of GSK2118436, as well as the effects of particle size on the relative bioavailability of GSK2118436.

Timeline

Start

2010-10-21

Primary completion

2011-05-13

Completion

2011-05-13

Publications

• Ouellet D, Grossmann KF, Limentani G, Nebot N, Lan K, Knowles L, Gordon MS, Sharma S, Infante JR, Lorusso PM, Pande G, Krachey EC, Blackman SC, Carson SW. Effects of particle size, food, and capsule shell composition on the oral bioavailability of dabrafenib, a BRAF inhibitor, in patients with BRAF mutation-positive tumors. J Pharm Sci. 2013 Sep;102(9):3100-9. doi: 10.1002/jps.23519. Epub 2013 Apr 22.

Drugs

Indications