Study in Healthy Males to Assess Bioavailability of 4 Different Fostamatinib Tablets

Completed · Phase 1

Conditions studied: Bioavailability, Pharmacokinetics

In brief

Study in healthy males to assess bioavailability of 4 different fostamatinib tablets

Key facts

Study ID

NCT01208155

Run by

AstraZeneca

People needed

24

Starts

2010-09-01

Expected to finish

2010-11-01

Last updated by the study team

2010-12-08

Who can join

Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Research Site — Overland Park, Kansas, United States

Full record on ClinicalTrials.gov

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