Clinical trial NCT01387308: Study in Healthy Males to Assess the Bioavailability of 4 Different Fostamatinib Tablets
Official title: An Open-label, Partially Randomized, 5-way Crossover Study in Healthy Volunteers to Assess the Relative Bioavailability of 100 and 150 mg Fostamatinib Tablets Compared With 50 mg Fostamatinib Tablets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
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
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-07-04
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Study in healthy males to assess bioavailability of 4 different fostamatinib tablets.


Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: From Pre-dose until 96 hours post dose of each treatment period
measure: 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)
timeFrame: From pre-dose until 96 hours post dose of each treatment period
Secondary outcomes:
measure: To examine the safety and tolerability of fostamatinib 50 mg, 100 mg, and 150 mg tablet batches
timeFrame: From pre-dose until 96 hours post dose of each treatment period
measure: To estimate the within subject variability in R406 exposure when fostamatinib 50 mg tablets are administered on 2 separate occasions.
timeFrame: From pre-dose until 96 hours post dose of each treatment period
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Research Site
state: Kansas
Study officials:
References: