Healthy Japanese Volunteers
Conditions
Keywords
fostamatinib, FosD, Japanese Healthy volunteers, Phase 1, Single and Multiple Dose Study
Brief summary
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.
Detailed description
A Phase I, Open-label Study to Assess the Pharmacokinetics of Oral Fostamatinib in Healthy Japanese Subjects After Single and Multiple Doses
Interventions
DRUGFostamatinib 100mg
oral tablet
DRUGFostamatinib 200mg
oral tablet
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic (PK) profile of fostamatinib from blood and urine in terms of AUC; tmax; Cmax; t1/2 and Rac. | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability profile in terms of adverse event monitoring, vital signs, physical examinations, clinical laboratory tests, 12 lead ECG | Up to Day 20 |
Countries
United States
Outcome results
None listed