Study in Healthy Males to Assess the Bioavailability of 4 Different Fostamatinib Tablets (NCT01387308) | Clinical Trial Compass
CompletedPhase 1
Study in Healthy Males to Assess the Bioavailability of 4 Different Fostamatinib Tablets
United States24 participantsStarted 2011-08
Plain-language summary
Study in healthy males to assess bioavailability of 4 different fostamatinib tablets.
Who can participate
Age range18 Years – 55 Years
SexMALE
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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
What they're measuring
1
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
2
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