A Single and Multiple Dose Study to Assess Blood and Urine Drug Levels of Fostamatinib in Healthy Japanese Subjects

December 18, 2012 updated by: AstraZeneca

A Phase I, Open-label Study to Assess the Pharmacokinetics of Oral Fostamatinib in Healthy Japanese Subjects After Single and Multiple Doses

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A Phase I, Open-label Study to Assess the Pharmacokinetics of Oral Fostamatinib in Healthy Japanese Subjects After Single and Multiple Doses

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Glendale, California, United States
    • Maryland
      • Baltimore, Maryland, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy male and female (of non-childbearing potential) Japanese subjects
  • 20 to 45 years of age
  • Body mass index (BMI) between 17 and 27 kg/m2 and weigh at least 45 kg and no more than 100 kg

Exclusion Criteria:

  • History or presence of respiratory, GI, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders
  • Any clinically significant illness, acute infection, known inflammatory process, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product
  • Smoking in excess of 5 cigarettes per day or equivalent within 30 days of Day 1
  • Use of prescription or over-the-counter drugs within 2 weeks of first administration of investigational product
  • Previous participation in a fostamatinib study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fostamatinib 100mg
Up to two cohorts of Japanese subjects are planned to receive fostamatinib 100mg single and multiple twice daily doses
Drug: Fostamatinib 100mg
oral tablet
Experimental: Fostamatinib 200mg
Up to two cohorts of Japanese subjects are planned to receive fostamatinib 200mg single and multiple twice daily doses
Drug: Fostamatinib 200mg
oral tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic (PK) profile of fostamatinib from blood and urine in terms of AUC; tmax; Cmax; t1/2 and Rac.
Time Frame: PK sampling at predose, 0, 0.25, 0.5, 1,1.5, 2, 4, 6, 8,12, 16, 24, 36, 48 and 72 hours post-dose following the single dose (on Day 1) and after repeated twice daily dosing on Days 4 and 10
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
PK sampling at predose, 0, 0.25, 0.5, 1,1.5, 2, 4, 6, 8,12, 16, 24, 36, 48 and 72 hours post-dose following the single dose (on Day 1) and after repeated twice daily dosing on Days 4 and 10

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability profile in terms of adverse event monitoring, vital signs, physical examinations, clinical laboratory tests, 12 lead ECG
Time Frame: Up to Day 20
Up to Day 20

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Mark Layton, MD, AstraZeneca
  • Principal Investigator: David Han, MD, PAREXEL Early Phase/California Clinical Trials Medical Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

May 30, 2012

First Submitted That Met QC Criteria

May 30, 2012

First Posted (Estimate)

May 31, 2012

Study Record Updates

Last Update Posted (Estimate)

December 19, 2012

Last Update Submitted That Met QC Criteria

December 18, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • D4300C00032

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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