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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01167868
Recruitment Status : Completed
First Posted : July 22, 2010
Last Update Posted : February 7, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Drug: FosD Drug: Placebo Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Phase I, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral Fostamatinib Disodium in Healthy Japanese and White Subjects After Single and Multiple Ascending Doses
Study Start Date : July 2010
Primary Completion Date : May 2011
Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: FosD
Four sequential cohorts of Japanese subjects are planned with doses ranging from 50mg once daily to a maximum of 200mg twice daily. One cohort of White subjects is also planned to receive the same dose regimen as the third dose level in Japanese subjects
Drug: FosD
oral tablet
Placebo Comparator: Placebo
Placebo given (2 subjects in each cohort)
Drug: Placebo
oral tablet


Outcome Measures

Primary Outcome Measures :
  1. To investigate safety and tolerability: adverse event monitoring, vital signs, physical examinations, clinical laboratory tests, 12 lead ECG, digital ECG, telemetry. [ Time Frame: Prior to treatment, during treatment, and a follow-up visit, a total of up to 20 days ]

Secondary Outcome Measures :
  1. To determine plasma PK parameters (including but not limited to: AUC, tmax, Cmax, terminal elimination half life (t1/2) and accumulation ratio (Rac)) of FosD. [ Time Frame: Plasma sampling for 72 hours following both the single dose and after 7 days repeated dosing. ]
  2. To determine urine PK parameters (including but not limited to: amount excreted (Ae) and renal clearance (CLr)) of FosD. [ Time Frame: Urine sampling for upto 48 hours following both the single dose and after 7 days repeated dosing. ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male and female (of non-childbearing potential) Japanese subjects and White subjects (origins in Europe, the Middle East, or North Africa)
  • 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01167868


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

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01167868     History of Changes
Other Study ID Numbers: D4300C00007
First Posted: July 22, 2010    Key Record Dates
Last Update Posted: February 7, 2013
Last Verified: February 2013

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