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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01608542
First received: May 30, 2012
Last updated: December 18, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Healthy Japanese Volunteers
 Drug: Fostamatinib 100mg
Drug: Fostamatinib 200mg
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Phase I, Open-label Study to Assess the Pharmacokinetics of Oral Fostamatinib in Healthy Japanese Subjects After Single and Multiple Doses

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 24
Study Start Date: June 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01608542

Locations
United States, California
Glendale, California, United States
United States, Maryland
Baltimore, Maryland, United States
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Mark Layton, MD AstraZeneca
Principal Investigator: David Han, MD PAREXEL Early Phase/California Clinical Trials Medical Group
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01608542     History of Changes
Other Study ID Numbers: D4300C00032
Study First Received: May 30, 2012
Last Updated: December 18, 2012
Health Authority: United States: Food and Drug Administration
US: Institutional Review Board

Keywords provided by AstraZeneca:
fostamatinib
FosD
Japanese Healthy volunteers
Phase 1
Single and Multiple Dose Study

ClinicalTrials.gov processed this record on May 19, 2013