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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01167868
First received: July 19, 2010
Last updated: February 6, 2013
Last verified: February 2013

July 19, 2010
February 6, 2013
July 2010
May 2011   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01167868 on ClinicalTrials.gov Archive Site
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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 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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Healthy
  • Drug: FosD
    oral tablet
  • Drug: Placebo
    oral tablet
  • 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
    Intervention: Drug: FosD
  • Placebo Comparator: Placebo
    Placebo given (2 subjects in each cohort)
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
May 2011
May 2011   (final data collection date for primary outcome measure)

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
Both
20 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01167868
D4300C00007
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: Mark Layton, MD AstraZeneca
Principal Investigator: Mark Yen, MD PAREXEL Early Phase/California Clinical Trials Medical Group
AstraZeneca
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP