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NCT00833378 · ClinicalTrials.gov registry record · Phase 1
Drug Interaction Study Between Eltrombopag and Lopinavir/Ritonavir in Healthy Adult Subjects.
A Phase 1 study of Hepatitis C, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT00833378 is a Phase 1 study of Hepatitis C that has completed, run by GlaxoSmithKline. The registered enrollment target is 40 participants, below the 1,890-participant average among 106 other Hepatitis C trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00833378, a Phase 1 study of Hepatitis C, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase I, open-label, single sequence, crossover study to be conducted in healthy adult subjects. There will be a screening visit, three treatment periods, and a follow-up visit. In Period 1, subjects will receive a single dose of eltrombopag on Day 1, and PK sampling will occur for 72 hours. In Period 2, subjects will receive LPV/RTV for 14 days with PK sampling for 12 hours. In Period 3, subjects will receive a single dose of eltrombopag with LPV/RTV 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.
Conditions Studied
Interventions
- DRUG Eltrombopag
- DRUG Lopinavir/Ritonavir
- DRUG Eltrombopag and Lopinavir/Ritonavir
Study Locations (1)
New York
- GSK Investigational Site - Buffalo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2009-01-19 |
| Est. Completion | 2009-03-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00833378
The ClinicalTrials.gov registry entry for NCT00833378 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, below the 1,890-participant average among 106 other Hepatitis C trials with a reported enrollment target (98% lower). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hepatitis C appearing as the primary indexed condition, and to 3 interventions - of which Eltrombopag is the first listed.
NCT00833378 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT00833378 about?
NCT00833378 is a clinical study titled "Drug Interaction Study Between Eltrombopag and Lopinavir/Ritonavir in Healthy Adult Subjects.". This is a Phase I, open-label, single sequence, crossover study to be conducted in healthy adult subjects. There will be a screening visit, three treatment periods, and a follow-up visit. In Period 1, subjects will receive a single dose of eltrombopag on Day 1, and PK sampling will occur for 72 hour...
What is the current status of trial NCT00833378?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2009-01-19. Estimated completion is 2009-03-11.
What conditions does trial NCT00833378 study?
This clinical trial studies the following conditions: Hepatitis C.
What interventions are being tested in trial NCT00833378?
The interventions under investigation include: Eltrombopag (DRUG), Lopinavir/Ritonavir (DRUG), Eltrombopag and Lopinavir/Ritonavir (DRUG).
Who is sponsoring clinical trial NCT00833378?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00833378 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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