An Open-label, Randomized, Four-way Crossover Study in Healthy Male Subjects to Assess the Relative Bioavailability of 4 Different Fostamatinib Tablets
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- 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 )
Study Overview
Brief Summary
Study in healthy males to assess bioavailability of 4 different fostamatinib tablets
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
1
Fostamatinib 50 mg tablet x 2
Intervention: Fostamatinib (Drug)
2
Fostamatinib 100 mg tablet (batch 1)
Intervention: Fostamatinib (Drug)
3
Fostamatinib 100 mg tablet (batch 2)
Intervention: Fostamatinib (Drug)
4
Fostamatinib 100 mg tablet (batch 4)
Intervention: Fostamatinib (Drug)
Outcomes
Primary Outcomes
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 )
Time Frame: Daily during Treatment Period 4 until 96 hours post dose of each treatment period
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 )
Time Frame: Daily during Treatment Period 4 until 96 hours post dose of each treatment period
Secondary Outcomes
- 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.(Screening, throughout the 4 treatment periods, and follow-up)