Study in Healthy Males to Assess the 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, Partially Randomized, 5-way Crossover Study in Healthy Volunteers to Assess the Relative Bioavailability of 100 and 150 mg Fostamatinib Tablets Compared With 50 mg Fostamatinib Tablets

Conditions
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Healthy

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of signed and dated informed consent prior to any study specific procedures Volunteers will be males aged 18 to 55 years and with a weight of at least 50 kg and body mass index (BMI) between 18 and 30 kg/m2 inclusive Volunteers agreeing to participate in the optional genetic research must provide a separate, signed, written and dated informed consent for genetic research. The volunteer will not be excluded from other aspects of the study described in this Clinical Study Protocol so long as they consent to them Exclusion Criteria: History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product Subjects who smoke more than 5 cigarettes or the equivalent in tobacco per day Any clinically significant abnormalities in clinical chemistry, haematology 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: A<br>Fostamatinib 50 mg tablet x 2 (Phase 3 batch) | Drug: Fostamatinib<br>* Oral tablets, 50 mg x 2, single dose<br>|
| Sham Comparator: B<br>Fostamatinib 50 mg tablet x 3 (Phase 3 batch) | Drug: Fostamatinib<br>* Oral tablets, 50 mg x 3, single dose<br>|
| Experimental: C<br>Fostamatinib 100 mg tablet (new formulation) | Drug: Fostamatinib<br>* Oral tablets, 100 mg, single dose<br>|
| Experimental: D<br>Fostamatinib 150 mg tablet (new formulation) | Drug: Fostamatinib<br>* Oral tablets, 150 mg, single dose<br>|
| Experimental: E<br>Fostamatinib 50 mg tablet x 2 (Phase 3 batch) | Drug: Fostamatinib<br>* Oral tablets, 50 mg x 2, single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the relative bioavailability of R406 in healthy volunteers when fostamatinib is administered as a reformulated 100-mg tablet versus 2 x 50-mg tablets (Phase III formulation) | Assessments will include but is not limited to: plasma R406 AUC, Cmax | From Pre-dose until 96 hours post dose of each treatment period | 
| To assess the relative bioavailability of R406 in healthy volunteers when fostamatinib is administered as a reformulated 150-mg tablet versus 3 x 50-mg tablets (Phase III formulation) | Assessments will include but is not limited to: plasma R406 AUC, Cmax ) | From pre-dose 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, 100 mg, and 150 mg tablet batches | The safety endpoints will include adverse event monitoring, vital signs, physical examinations, clinical laboratory tests, ECGs. | From pre-dose until 96 hours post dose of each treatment period | 
| To estimate the within subject variability in R406 exposure when fostamatinib 50 mg tablets are administered on 2 separate occasions. | Assessments will include but is not limited to: plasma R406 plasma AUC0-t, t1/2, and tmax | From pre-dose until 96 hours post dose of each treatment period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase 1, Healthy male volunteers, pharmacokinetics, fostamatinib, Scientific Terminology: Bioavailability, R406 plasma AUC and C_maxR406 plasma AUC0-t, t1/2λz and t_max, Laymen Terminology: Amount of R406 in blood