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NCT01167868 · ClinicalTrials.gov registry record · Phase 1

A Study to Assess the Safety, Tolerability, and Blood and Urine Drug Levels of Fostamatinib Disodium (FosD) in Healthy Japanese and White Subjects

A Phase 1 study, sponsored by AstraZeneca.

Completed
Registry status
Phase 1
Development phase
56
Enrollment target

NCT01167868: Completed Phase 1 study, sponsored by AstraZeneca.

NCT01167868 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 56 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01167868, a Phase 1 study, has completed, sponsored by AstraZeneca.

COMPLETED
Registry status
Phase 1
Development phase
56 participants
Enrollment target

Study Summary

This is a single and multiple ascending dose study in healthy male and female (of non-child bearing potential) Japanese and White volunteers, to assess the safety, tolerability, and blood and urine drug levels of FosD. FosD is being developed for the treatment of rheumatoid arthritis.

Interventions

  • DRUG Placebo
  • DRUG FosD

Trial Details

FieldValue
Enrollment Target 56 participants
Start Date 2010-07
Est. Completion 2011-05
Phase Phase 1
AstraZeneca

1,285 total trials

What the finished NCT01167868 record still lists

NCT01167868 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01167868 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01167868 about?

NCT01167868 is a clinical study titled "A Study to Assess the Safety, Tolerability, and Blood and Urine Drug Levels of Fostamatinib Disodium (FosD) in Healthy Japanese and White Subjects". This is a single and multiple ascending dose study in healthy male and female (of non-child bearing potential) Japanese and White volunteers, to assess the safety, tolerability, and blood and urine drug levels of FosD. FosD is being developed for the treatment of rheumatoid arthritis.

What is the current status of trial NCT01167868?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2010-07. Estimated completion is 2011-05.

What interventions are being tested in trial NCT01167868?

The interventions under investigation include: Placebo (DRUG), FosD (DRUG).

Who is sponsoring clinical trial NCT01167868?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01167868's enrollment target sits among peer trials

56 902nd of 2000 higher than 1,083 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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Source: ClinicalTrials.gov NCT01167868, the US trial registry maintained by the National Library of Medicine. NCT01167868 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.