Spots Global Cancer Trial Database for GSK1120212 Food-effect Study

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Trial Identification

Brief Title: GSK1120212 Food-effect Study

Official Title: An Open-Label, Two-Period, Randomized, Crossover Study to Evaluate the Effect of Food on the Single Dose Pharmacokinetics of the MEK Inhibitor, GSK1120212, in Subjects With Solid Tumors

Study ID: NCT01371487

Conditions

Cancer

Interventions

GSK1120212

Study Description

Brief Summary: The purpose of the this study is to evaluate the effect of a high-fat, high calorie meal on the single dose PK of GSK1120212 in subjects with solid tumors.

Detailed Description: open-label, randomized, 2-treatment, 2-period, crossover study with incomplete wash-out to evaluate the effect of a high-fat, high calorie meal on the single dose PK of GSK1120212 in subjects with solid tumors. Subjects will be assigned to a fast/fed sequence according to the randomization code provided to the sites by GSK with subjects randomized to one of 2 possible treatment sequences (Table 1) with each sequence consisting of 2 treatments: a single 2.0 mg dose of GSK1120212 administered under fasted conditions and a single 2.0 mg dose of GSK1120212 administered with a high-fat, high-calorie meal