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

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

Official Title
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An Open-label, Randomized, Four-way Crossover Study in Healthy Male Subjects to Assess the Relative Bioavailability of 4 Different Fostamatinib Tablets

Conditions
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Bioavailability, Pharmacokinetics

Intervention / Treatment
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* Drug: Fostamatinib
* Drug: Fostamatinib
* Drug: Fostamatinib
* Drug: Fostamatinib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Fostamatinib 50 mg tablet x 2 | Drug: Fostamatinib<br>* Oral tablets, 50 mg x 2, single dose<br>|
| Experimental: 2<br>Fostamatinib 100 mg tablet (batch 1) | Drug: Fostamatinib<br>* Oral tablets, 100 mg Batch 1, single dose<br>|
| Experimental: 3<br>Fostamatinib 100 mg tablet (batch 2) | Drug: Fostamatinib<br>* Oral tablets, 100 mg Batch 2, single dose<br>|
| Experimental: 4<br>Fostamatinib 100 mg tablet (batch 4) | Drug: Fostamatinib<br>* Oral tablets, 100 mg Batch 3, single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 ) |  | Daily during Treatment Period 1 until 96 hours post dose of each treatment period | 
| 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 ) |  | Daily during Treatment Period 2 until 96 hours post dose of each treatment period | 
| 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 ) |  | Daily during Treatment Period 3 until 96 hours post dose of each treatment period | 
| 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 ) |  | 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 ) |  | Daily during Treatment Period 1 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 ) |  | Daily during Treatment Period 2 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 ) |  | Daily during Treatment Period 3 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 ) |  | Daily during Treatment Period 4 until 96 hours post dose of each treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase 1, Healthy, pharmacokinetics, Fostamatinib