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NCT01608542 · ClinicalTrials.gov registry record · Phase 1
A Single and Multiple Dose Study to Assess Blood and Urine Drug Levels of Fostamatinib in Healthy Japanese Subjects
A Phase 1 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT01608542: Completed Phase 1 study, sponsored by AstraZeneca.
NCT01608542 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01608542, a Phase 1 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
This is a single and multiple dose study in healthy male and female (of non-child bearing potential) Japanese volunteers, to assess the blood and urine drug levels of Fostamatinib. Fostamatinib is being developed for the treatment of rheumatoid arthritis.
Primary Outcome
AUC - area under the plasma concentration time curve from zero to infinity ; tmax - time to max plasma concentration; t1/2 - terminal elimination half life; Rac - accumulation ratio
Interventions
- DRUG Fostamatinib 100mg
- DRUG Fostamatinib 200mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2012-06 |
| Est. Completion | 2012-08 |
| Phase | Phase 1 |
What the finished NCT01608542 record still lists
NCT01608542 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which Fostamatinib 100mg is the first listed.
NCT01608542 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01608542 about?
NCT01608542 is a clinical study titled "A Single and Multiple Dose Study to Assess Blood and Urine Drug Levels of Fostamatinib in Healthy Japanese Subjects". This is a single and multiple dose study in healthy male and female (of non-child bearing potential) Japanese volunteers, to assess the blood and urine drug levels of Fostamatinib. Fostamatinib is being developed for the treatment of rheumatoid arthritis.
What is the current status of trial NCT01608542?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2012-06. Estimated completion is 2012-08.
What interventions are being tested in trial NCT01608542?
The interventions under investigation include: Fostamatinib 100mg (DRUG), Fostamatinib 200mg (DRUG).
Who is sponsoring clinical trial NCT01608542?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01608542's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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