Healthy
Conditions
Keywords
Phase 1, Healthy male volunteers, pharmacokinetics, fostamatinib, Scientific Terminology: Bioavailability, R406 plasma AUC and C_maxR406 plasma AUC0-t, t1/2λz and t_max, Laymen Terminology: Amount of R406 in blood
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
* Provision of signed and dated informed consent prior to any study specific procedures * Volunteers will be males aged 18 to 55 years and with a weight of at least 50 kg and body mass index (BMI) between 18 and 30 kg/m2 inclusive * Volunteers agreeing to participate in the optional genetic research must provide a separate, signed, written and dated informed consent for genetic research. The volunteer will not be excluded from other aspects of the study described in this Clinical Study Protocol so long as they consent to them
Exclusion criteria
* History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study * History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs * Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product * Subjects who smoke more than 5 cigarettes or the equivalent in tobacco per day * Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the relative bioavailability of R406 in healthy volunteers when fostamatinib is administered as a reformulated 100-mg tablet versus 2 x 50-mg tablets (Phase III formulation) | From Pre-dose until 96 hours post dose of each treatment period | Assessments will include but is not limited to: plasma R406 AUC, Cmax |
| To assess the relative bioavailability of R406 in healthy volunteers when fostamatinib is administered as a reformulated 150-mg tablet versus 3 x 50-mg tablets (Phase III formulation) | From pre-dose until 96 hours post dose of each treatment period | Assessments will include but is not limited to: plasma R406 AUC, Cmax ) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To examine the safety and tolerability of fostamatinib 50 mg, 100 mg, and 150 mg tablet batches | From pre-dose until 96 hours post dose of each treatment period | The safety endpoints will include adverse event monitoring, vital signs, physical examinations, clinical laboratory tests, ECGs. |
| To estimate the within subject variability in R406 exposure when fostamatinib 50 mg tablets are administered on 2 separate occasions. | From pre-dose until 96 hours post dose of each treatment period | Assessments will include but is not limited to: plasma R406 plasma AUC0-t, t1/2, and tmax |
Countries
United States
Outcome results
None listed