Cancer Clinical Trial
Official title:
Determination of the Absolute Bioavailability of GSK1120212 Following a Single Oral Dose Co-Administered With an Intravenous Radiolabelled Microdose of GSK1120212 in Subjects With Solid Tumors
A Phase I, single-center, open-label, single-persiod, combined single dose oral and IV microtracer study in subjects with solid tumors.
This Phase I, open-label, non-randomized study is designed to determine the absolute bioavailability of the standard 2 mg tablet formulation of GSK1120212 co-administered with an intravenous microdose (5 μg) dose of [14C]-labelled GSK1120212 (7.4 kBq) in subjects with solid tumors. Pharmacokinetic sampleswill be obtained up to 10 days post-dose. Safety assessments, including assessment of adverse events, clinical laboratory values (hematology and clinical chemistry) and vital signs, will be performed throughout the study. After completing all assessments, eligible subjects may transition to MEK114375, an open-label, rollover study to continue treatment with GSK1120212. ;
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