Study in Healthy Males to Assess Bioavailability of 4 Different Fostamatinib Tablets
NCT ID: NCT01208155
Last Updated: 2010-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2010-09-30
2010-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Fostamatinib 50 mg tablet x 2
Fostamatinib
Oral tablets, 50 mg x 2, single dose
2
Fostamatinib 100 mg tablet (batch 1)
Fostamatinib
Oral tablets, 100 mg Batch 1, single dose
3
Fostamatinib 100 mg tablet (batch 2)
Fostamatinib
Oral tablets, 100 mg Batch 2, single dose
4
Fostamatinib 100 mg tablet (batch 4)
Fostamatinib
Oral tablets, 100 mg Batch 3, single dose
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Fostamatinib
Oral tablets, 50 mg x 2, single dose
Fostamatinib
Oral tablets, 100 mg Batch 1, single dose
Fostamatinib
Oral tablets, 100 mg Batch 2, single dose
Fostamatinib
Oral tablets, 100 mg Batch 3, single dose
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 Criteria
* 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
18 Years
55 Years
MALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AstraZeneca
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
AstraZeneca
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mark Layton, MD
Role: STUDY_DIRECTOR
AstraZeneca
Carlos Prendes, MD
Role: PRINCIPAL_INVESTIGATOR
Quintiles, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Overland Park, Kansas, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
D4300C00016
Identifier Type: -
Identifier Source: org_study_id