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NCT01072162 · ClinicalTrials.gov registry record · Phase 1
Relative Bioavailibilty for Pediatric Powder for Suspension (PfOS) Formulation and Food Effect
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT01072162 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 40 participants.
The verdict
NCT01072162, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
This is a randomized, open-label, five-period, balanced crossover study conducted in approximately 40 healthy adult subjects enrolled at one study center in the USA. Subjects receive five eltrombopag treatments: tablet fasted, Powder for Oral Suspension (PfOS) fasted, PfOS with a high calcium meal, PfOS 2 hours prior to a high calcium meal, and PfOS 2 hours after a high calcium meal, and each treatment is a single 25 mg dose. There is a 10 to 14 day washout between periods, and between the last dose of study drug and the follow-up visit. During each treatment period, subjects undergo serial PK sampling over 72 hours for measurement of plasma eltrombopag concentrations. Safety is assessed by vital signs, clinical safety laboratory assessments, and adverse events reporting.
Interventions
- DRUG Eltrombopag
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2010-01-12 |
| Est. Completion | 2010-04-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01072162
The ClinicalTrials.gov registry entry for NCT01072162 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 40 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 1 intervention - of which Eltrombopag is the first listed.
NCT01072162 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01072162 about?
NCT01072162 is a clinical study titled "Relative Bioavailibilty for Pediatric Powder for Suspension (PfOS) Formulation and Food Effect". This is a randomized, open-label, five-period, balanced crossover study conducted in approximately 40 healthy adult subjects enrolled at one study center in the USA. Subjects receive five eltrombopag treatments: tablet fasted, Powder for Oral Suspension (PfOS) fasted, PfOS with a high calcium meal, ...
What is the current status of trial NCT01072162?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2010-01-12. Estimated completion is 2010-04-07.
What interventions are being tested in trial NCT01072162?
The interventions under investigation include: Eltrombopag (DRUG).
Who is sponsoring clinical trial NCT01072162?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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