Bioavailability, Pharmacokinetics
Conditions
Keywords
Phase 1, Healthy, pharmacokinetics, Fostamatinib
Brief summary
Study in healthy males to assess bioavailability of 4 different fostamatinib tablets
Interventions
DRUGFostamatinib
Oral tablets, 50 mg x 2, single dose
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Weight of at least 50 kg and body mass index (BMI) between 18.0 and 35.0 kg/m2 inclusive * Volunteers must be willing to use barrier contraception ie, condoms, from the Day 1 of Treatment Period 1 until 2 weeks after the final dosing of the investigational product (IP)
Exclusion criteria
* History of any clinically significant disease or disorder * History or presence of GI, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs (except for cholecystectomy) * Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of drug * Volunteers who smoke more than 5 cigarettes or the equivalent in tobacco per day * Any clinically significant abnormalities in clinical chemistry, hematology or urinalysis results as judged by the Investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relative bioavailability of R406 when fostamatinib is administered as 50 mg tablets versus 3 different 100 mg tablet batches (assessment will include but is not limited to: plasma R406 AUC, Cmax ) | Daily during Treatment Period 1 until 96 hours post dose of each treatment period |
| Relative bioavailability of R406 when fostamatinib is administered as 3 different 100 mg tablet batches (assessment will include but is not limited to: plasma R406 AUC, Cmax ) | Daily during Treatment Period 1 until 96 hours post dose of each treatment period |
Secondary
| Measure | Time frame |
|---|---|
| To examine the safety and tolerability of fostamatinib 50 mg and 100 mg tablet batches The safety endpoints will include: adverse event monitoring, vital signs, physical examinations, clinical laboratory tests, ECGs. | Screening, throughout the 4 treatment periods, and follow-up |
Countries
United States
Outcome results
None listed