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NCT02281370 · ClinicalTrials.gov registry record · Phase 1
Drug-drug Interaction Study of Eltrombopag and Cyclosporine in Healthy Subjects
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 39
- Enrollment target
NCT02281370 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 39 participants.
The verdict
NCT02281370, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 39 participants
- Enrollment target
Study Summary
A drug-drug interaction study between eltrombopag and cyclosporine is being conducted to support the use of these drugs together in subjects, such as those with severe aplastic anemia or immune thrombocytopenia purpura. The primary objective of the study is to evaluate the effect of cyclosporine on the pharmacokinetics of eltrombopag. This is a Phase I, open-label, randomized, three-period cross-over study in healthy adult subjects. The study consists of a screening visit and three treatment periods. All subjects will be randomized to receive one of the three treatments in each treatment period separated by washout periods of 3-10 days. The total duration of a subject's participation in the study from screening to final discharge is up to approximately 6 weeks (assuming 3 day washouts between treatment periods). Approximately 39 healthy subjects will be enrolled with the goal of completing at least 10 subjects per sequence (total 30).
Interventions
- DRUG Cyclosporine
- DRUG Eltrombopag
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2014-11-05 |
| Est. Completion | 2014-12-24 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02281370
The ClinicalTrials.gov registry entry for NCT02281370 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 39 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 Cyclosporine is the first listed.
NCT02281370 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02281370 about?
NCT02281370 is a clinical study titled "Drug-drug Interaction Study of Eltrombopag and Cyclosporine in Healthy Subjects". A drug-drug interaction study between eltrombopag and cyclosporine is being conducted to support the use of these drugs together in subjects, such as those with severe aplastic anemia or immune thrombocytopenia purpura. The primary objective of the study is to evaluate the effect of cyclosporine on ...
What is the current status of trial NCT02281370?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2014-11-05. Estimated completion is 2014-12-24.
What interventions are being tested in trial NCT02281370?
The interventions under investigation include: Cyclosporine (DRUG), Eltrombopag (DRUG).
Who is sponsoring clinical trial NCT02281370?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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