Spots Global Cancer Trial Database for Relative Bioavailibilty for Pediatric Powder for Suspension (PfOS) Formulation

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Trial Identification

Brief Title: Relative Bioavailibilty for Pediatric Powder for Suspension (PfOS) Formulation

Official Title: An Open-Label, Two-Period, Randomized, Crossover Study to Assess the Relative Bioavailability of GSK1120212 Tablet Formulation and the GSK1120212 Pediatric Oral Solution Formulation Following Single-Dose Administration to Adult Subjects With Solid Tumors

Study ID: NCT01647659

Conditions

Cancer

Interventions

Trametinib tablet

Trametinib pediatric formulation

Study Description

Brief Summary: The purpose of this open-label, randomized, 2-treatment, 2-period crossover study with incomplete washout is to evaluate the relative bioavailability of 2mg GSK1120212 pediatric oral solution formulation in comparison to 2mg GSK1120212 tablet formulation, to investigate the safety and tolerability of a single dose of the GSK1120212 pediatric oral solution formulation as compared to a single dose of the GSK1120212 tablet formulation, and to investigate the palatability of the GSK1120212 pediatric oral solution formulation. Subjects will be assigned to one of two possible treatment sequences according to the randomization code provided to the sites by GSK: a single dose of 2mg GSK1120212 pediatric oral solution formulation then a single dose of 2mg GSK1120212 tablet formulation, or a single dose of 2mg GSK1120212 tablet formulation, then a single dose of 2mg GSK1120212 pediatric oral solution formulation. Administration of GSK1120212 in either sequence will be followed by 7 days of serial blood sampling for pharmacokinetic analysis of plasma GSK1120212. Safety assessments, including assessment of adverse events, clinical laboratory values (hematology, clinical chemistry and urinalysis) and vital signs, will be made throughout the study. After completing the pharmacokinetic assessments for two periods, eligible subjects may transition to MEK114375, an open-label rollover study of GSK1120212.

Detailed Description: The purpose of this open-label, randomized, 2-treatment, 2-period crossover study with incomplete washout is to evaluate the relative bioavailability of 2mg GSK1120212 pediatric oral solution formulation in comparison to 2mg GSK1120212 tablet formulation, to investigate the safety and tolerability of a single dose of the GSK1120212 pediatric oral solution formulation as compared to a single dose of the GSK1120212 tablet formulation, and to investigate the palatability of the GSK1120212 pediatric oral solution formulation. Subjects will be assigned to one of two possible treatment sequences according to the randomization code provided to the sites by GSK: a single dose of 2mg GSK1120212 pediatric oral solution formulation then a single dose of 2mg GSK1120212 tablet formulation, or a single dose of 2mg GSK1120212 tablet formulation, then a single dose of 2mg GSK1120212 pediatric oral solution formulation. Administration of GSK1120212 in either sequence will be followed by 7 days of serial blood sampling for pharmacokinetic analysis of plasma GSK1120212. Safety assessments, including assessment of adverse events, clinical laboratory values (hematology, clinical chemistry and urinalysis) and vital signs, will be made throughout the study. After completing the pharmacokinetic assessments for two periods, eligible subjects may transition to MEK114375, an open-label rollover study of GSK1120212.