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NCT01647659 · ClinicalTrials.gov registry record · Phase 1
Relative Bioavailibilty for Pediatric Powder for Suspension (PfOS) Formulation
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT01647659 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 18 participants.
The verdict
NCT01647659, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study 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.
Interventions
- DRUG Trametinib tablet
- DRUG Trametinib pediatric formulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2012-07-30 |
| Est. Completion | 2012-11-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01647659
The ClinicalTrials.gov registry entry for NCT01647659 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Trametinib tablet is the first listed.
NCT01647659 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01647659 about?
NCT01647659 is a clinical study titled "Relative Bioavailibilty for Pediatric Powder for Suspension (PfOS) Formulation". 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 o...
What is the current status of trial NCT01647659?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2012-07-30. Estimated completion is 2012-11-12.
What interventions are being tested in trial NCT01647659?
The interventions under investigation include: Trametinib tablet (DRUG), Trametinib pediatric formulation (DRUG).
Who is sponsoring clinical trial NCT01647659?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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