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

Conditions

• Healthy Japanese Volunteers

Eligibility Criteria

Sex

ALL

Age

20 Years - 45 Years

Healthy Volunteers

Accepted

Interventions

• Fostamatinib 100mg — DRUG
  oral tablet
• Fostamatinib 200mg — DRUG
  oral tablet

Study Details

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.

Key Dates

Start date

Jun 30, 2012

Status verified

Dec 2012

Primary completion

Aug 31, 2012

Completion

Aug 31, 2012

Study Design

Enrollment

24 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Arms

• Experimental: Fostamatinib 100mg
  Up to two cohorts of Japanese subjects are planned to receive fostamatinib 100mg single and multiple twice daily doses
• Experimental: Fostamatinib 200mg
  Up to two cohorts of Japanese subjects are planned to receive fostamatinib 200mg single and multiple twice daily doses

Primary Outcome Measure

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 ]

Locations (2)