Relative Bioavailibilty for Pediatric Powder for Suspension (PfOS) Formulation

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
GlaxoSmithKline
Study ID
NCT01647659
Phase
PHASE1
Status
Completed

Conditions

  • Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jul 30, 2012
Status verified
Nov 2017
Primary completion
Nov 12, 2012
Completion
Nov 12, 2012

Study Design

Enrollment
18 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: GSK1120212 tablet
    GSK1120212 tablet
  • Experimental: GSK1120212 powder for oral solution
    GSK1120212 powder for oral solution

Primary Outcome Measure

Evaluate the relative bioavailability of a PfOS formulation relative to the commercial GSK1120212 tablet formulation in adult subjects with solid tumors [ Time Frame: 168 hours X 2 ]

Locations (2)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteScottsdaleArizona85259-
GSK Investigational SiteNashvilleTennessee37203-

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GSK Investigational Site· Scottsdale, AZGSK Investigational Site· Nashville, TN

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