Clinical trial NCT01208155: Study in Healthy Males to Assess Bioavailability of 4 Different Fostamatinib Tablets
Official title: An Open-label, Randomized, Four-way Crossover Study in Healthy Male Subjects to Assess the Relative Bioavailability of 4 Different Fostamatinib Tablets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bioavailability
Pharmacokinetics
Keywords: Phase 1
Healthy
pharmacokinetics
Fostamatinib
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-09-23
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:

* 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 Criteria:

* 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

Primary outcomes:
measure: Relative bioavailability of R406 when fostamatinib is administered as 50 mg tablets versus 3 different 100 mg tablet batches (assessment will include but is not limited to: plasma R406 AUC, Cmax )
timeFrame: Daily during Treatment Period 1 until 96 hours post dose of each treatment period
measure: Relative bioavailability of R406 when fostamatinib is administered as 50 mg tablets versus 3 different 100 mg tablet batches (assessment will include but is not limited to: plasma R406 AUC, Cmax )
timeFrame: Daily during Treatment Period 2 until 96 hours post dose of each treatment period
measure: Relative bioavailability of R406 when fostamatinib is administered as 50 mg tablets versus 3 different 100 mg tablet batches (assessment will include but is not limited to: plasma R406 AUC, Cmax )
timeFrame: Daily during Treatment Period 3 until 96 hours post dose of each treatment period
measure: Relative bioavailability of R406 when fostamatinib is administered as 50 mg tablets versus 3 different 100 mg tablet batches (assessment will include but is not limited to: plasma R406 AUC, Cmax )
timeFrame: Daily during Treatment Period 4 until 96 hours post dose of each treatment period
measure: Relative bioavailability of R406 when fostamatinib is administered as 3 different 100 mg tablet batches (assessment will include but is not limited to: plasma R406 AUC, Cmax )
timeFrame: Daily during Treatment Period 1 until 96 hours post dose of each treatment period
measure: Relative bioavailability of R406 when fostamatinib is administered as 3 different 100 mg tablet batches (assessment will include but is not limited to: plasma R406 AUC, Cmax )
timeFrame: Daily during Treatment Period 2 until 96 hours post dose of each treatment period
measure: Relative bioavailability of R406 when fostamatinib is administered as 3 different 100 mg tablet batches (assessment will include but is not limited to: plasma R406 AUC, Cmax )
timeFrame: Daily during Treatment Period 3 until 96 hours post dose of each treatment period
measure: Relative bioavailability of R406 when fostamatinib is administered as 3 different 100 mg tablet batches (assessment will include but is not limited to: plasma R406 AUC, Cmax )
timeFrame: Daily during Treatment Period 4 until 96 hours post dose of each treatment period
Secondary outcomes:
measure: To examine the safety and tolerability of fostamatinib 50 mg and 100 mg tablet batches The safety endpoints will include: adverse event monitoring, vital signs, physical examinations, clinical laboratory tests, ECGs.
timeFrame: Screening, throughout the 4 treatment periods, and follow-up
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Research Site
state: Kansas
Study officials:
affiliation: AstraZeneca
name: Mark Layton, MD
role: STUDY_DIRECTOR
affiliation: Quintiles, Inc.
name: Carlos Prendes, MD
role: PRINCIPAL_INVESTIGATOR
References: