Status:
COMPLETED
Study in Healthy Males to Assess Bioavailability of 4 Different Fostamatinib Tablets
Lead Sponsor:
AstraZeneca
Conditions:
Bioavailability
Pharmacokinetics
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
Study in healthy males to assess bioavailability of 4 different fostamatinib tablets
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01208155
Start Date
September 1 2010
End Date
November 1 2010
Last Update
December 8 2010
Active Locations (1)
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1
Research Site
Overland Park, Kansas, United States