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NCT02039076 · ClinicalTrials.gov registry record · Phase 1
A Five-Treatment-Period Study to Evaluate the Single-Dose Pharmacokinetics and Pharmacodynamics of Avatrombopag in Healthy Japanese and White Subjects
A Phase 1 study of Thrombocytopenia, sponsored by Eisai.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
- 1
- Study location
NCT02039076: Completed Phase 1 study of Thrombocytopenia, sponsored by Eisai.
NCT02039076 is a Phase 1 study of Thrombocytopenia that has completed, run by Eisai. The registered enrollment target is 48 participants, below the 310-participant average among 20 other Thrombocytopenia trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02039076, a Phase 1 study of Thrombocytopenia, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
- 1
- Study location
Study Summary
This will be a randomized, open-label, 5-treatment-period study to evaluate the PK and PD of avatrombopag following a single administration of avatrombopag in the fed and fasted condition, or the fed condition, to healthy Japanese and white subjects. A standard high-fat, high calorie breakfast will be used to assess the fed condition.
Primary Outcome
The following PK parameters will be estimated for plasma: Cmax, AUC, and t1/2.
Conditions Studied
Interventions
- DRUG avatrombopag
Study Locations (1)
California
- Parexel International Early Development Clinical Units - Glendale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2013-12 |
| Est. Completion | 2014-09 |
| Phase | Phase 1 |
What the finished NCT02039076 record still lists
NCT02039076 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 310-participant average among 20 other Thrombocytopenia trials with a reported enrollment target (85% lower).
The record links to 1 condition, with Thrombocytopenia appearing as the primary indexed condition, and to 1 intervention - of which avatrombopag is the first listed.
NCT02039076 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT02039076 about?
NCT02039076 is a clinical study titled "A Five-Treatment-Period Study to Evaluate the Single-Dose Pharmacokinetics and Pharmacodynamics of Avatrombopag in Healthy Japanese and White Subjects". This will be a randomized, open-label, 5-treatment-period study to evaluate the PK and PD of avatrombopag following a single administration of avatrombopag in the fed and fasted condition, or the fed condition, to healthy Japanese and white subjects. A standard high-fat, high calorie breakfast will ...
What is the current status of trial NCT02039076?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2013-12. Estimated completion is 2014-09.
What conditions does trial NCT02039076 study?
This clinical trial studies the following conditions: Thrombocytopenia.
What interventions are being tested in trial NCT02039076?
The interventions under investigation include: avatrombopag (DRUG).
Who is sponsoring clinical trial NCT02039076?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02039076 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02039076's enrollment target sits among peer trials
48 11th of 20 higher than 10 of 20 other Thrombocytopenia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Thrombocytopenia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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