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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 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 56 participants.

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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

Sponsor

AstraZeneca

1,285 total trials

What the Registry Record Tells You About NCT01167868

The ClinicalTrials.gov registry entry for NCT01167868 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.

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

NCT01167868 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.