Study in Healthy Males to Assess Bioavailability of Single Fostamatinib With iv Micro Tracer Dose

Study Overview
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Brief Summary
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Study in healthy males to assess bioavailability of single fostamatinib with iv micro tracer dose.

Detailed Description
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A Study to Assess the Absolute Bioavailability of a Single Oral Dose of Fostamatinib with Respect to an Intravenous Micro Tracer Dose of [14C] R406 in Healthy Male Volunteers.

Official Title
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A Study to Assess the Absolute Bioavailability of a Single Oral Dose of Fostamatinib With Respect to an Intravenous Micro Tracer Dose of [14C] R406 in Healthy Male Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: Fostamatinib
* Drug: Fostamatinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male volunteers aged 18 to 55 years (inclusive), with a weight of at least 50 kg and a body mass index (BMI) between 18 and 30 kg/m2 (inclusive) Male volunteers willing to use barrier contraception ie, condoms with spermicide, from the first day of the investigational product administration until 3 months after the last administration of the investigational product 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 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fostamatinib 50 mg tablet<br> | Drug: Fostamatinib<br>* Fostamatinib 50 mg tablet<br>|
| Experimental: Fostamatinib 100 μg [14C] R406 intravenous micro tracer dose<br> | Drug: Fostamatinib<br>* Fostamatinib 100 μg [14C] R406 intravenous micro tracer dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percent of absolute bioavailability (F) of R406 after oral administration of fostamatinib. |  | Up to 96 hours post dose | 
| Total radioactivity of [14C] R406 after an intravenous infusion of [14C]R406 in terms of AUC, AUC(0-t), Cmax, t1/2λz, MRT, CL, Vz. | AUC-Area under the plasma concentration time curve; AUC(0-t)-Area under plasma concentration time curve from zero to time of the last measurable concentration; Cmax - max plasma concentration; t½ λz-Terminal half-life; MRT- Mean residence time; CL - Total body clearance; Vz - Volume of distribution during the terminal phase | Up to 96 hours post dose | 
| Pharmacokinetic (PK) profile of a single oral dose of fostamatinib and a radiolabelled intravenous micro tracer dose of [14C] R406. | PK Parameters: AUC, AUC (0-t), Cmax, t½ λz and MRT | 0, 30min, 1h, 1h 30min, 1h 45min, 1h 50min, 1h 55min, 2, 2h 5min, 2h 10min, 2h 15min, 2h30min, 3, 3h 30min, 5h30min, 9h, 12h, 18h, 24h, 30h, 48h, 72h, 96h post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with Adverse Events. |  | Up to Day 12 | 
| Safety profile in terms of vital signs (blood pressure and pulse), clinical laboratory tests, ECGs and physical examination findings. |  | Up to Day 12 | 

 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, Bioavailability, R406 plasma AUC and Cmax, R406 plasma AUC0-t, t1/2λz, tmax