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NCT01657552 · ClinicalTrials.gov registry record · Phase 1
Eltrombopag/Boceprevir and Eltrombopag/Telaprevir Drug-Drug Interaction Study In Healthy Adult Subjects
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 56
- Enrollment target
NCT01657552 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 56 participants.
The verdict
NCT01657552, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 56 participants
- Enrollment target
Study Summary
The purpose of the current Phase I, open-label, three-period, single sequence, crossover study, TPL116010, is to evaluate the potential drug-drug interaction between eltrombopag (ELT) and bocrprevir (BCP) and between ELT and telaprevir (TLP) in healthy subjects. In this study there will be a screening visit, three treatment periods, and a follow-up visit. In Period 1, subjects will receive a single dose of ELT on Day 1, and pharmacokinetic (PK) sampling will occur for 72 hours. In Period 2, subjects will receive BCP/TLP for 10 days with PK sampling for 8 hours. In Period 3, subjects will receive a single dose of ELT with BCP/TLP on Day 1 only with PK sampling for 72 hours. Subjects will return for a follow-up visit within 10 to 14 days of the last dose of study drugs. The total duration of the study from Screening to Follow-up will be approximately 9 weeks.
Interventions
- DRUG Eltrombopag
- DRUG Telaprevir
- DRUG Boceprevir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2012-08-01 |
| Est. Completion | 2012-10-26 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01657552
The ClinicalTrials.gov registry entry for NCT01657552 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 56 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 3 interventions - of which Eltrombopag is the first listed.
NCT01657552 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01657552 about?
NCT01657552 is a clinical study titled "Eltrombopag/Boceprevir and Eltrombopag/Telaprevir Drug-Drug Interaction Study In Healthy Adult Subjects". The purpose of the current Phase I, open-label, three-period, single sequence, crossover study, TPL116010, is to evaluate the potential drug-drug interaction between eltrombopag (ELT) and bocrprevir (BCP) and between ELT and telaprevir (TLP) in healthy subjects. In this study there will be a screeni...
What is the current status of trial NCT01657552?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2012-08-01. Estimated completion is 2012-10-26.
What interventions are being tested in trial NCT01657552?
The interventions under investigation include: Eltrombopag (DRUG), Telaprevir (DRUG), Boceprevir (DRUG).
Who is sponsoring clinical trial NCT01657552?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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