Effects of Administration of Fostamatinib on Blood Concentrations of Rifampicin in Healthy Subjects.

Study Overview
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Brief Summary
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The purpose of this study is to investigate the drug interaction between fostamatinib and rifampicin by comparing the safety, tolerability and plasma concentration of fostamatinib when administered alone and with rifampicin in healthy subjects

Official Title
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An Open-Label, Non-Randomized, 2-Period, Single Center Study to Assess the Single Dose Pharmacokinetics of R406 in Healthy Subjects When Fostamatinib 150 mg is Administered Alone and in Combination With Rifampicin

Conditions
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Rheumatoid Arthritis, Healthy Volunteers

Intervention / Treatment
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* Drug: fostamatinib
* Drug: rifampicin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of informed consent prior to any study specific procedures Males or females aged 18 to 55 years (inclusive) Minimum weight of 50 kg and a body mass index (BMI) of 18 to 35 kg/m2 (inclusive) Female subjects must have a negative pregnancy test at screening and admission of each treatment period, must not be lactating, and must be of non-childbearing potential Exclusion Criteria: History or presence of gastrointestinal, hepatic or renal disease (except for cholecystectomy) Any clinically significant illness, medical or surgical procedure, or trauma within 4 weeks before Period 1 Day 1 Subjects who smoke more than 5 cigarettes or the equivalent in tobacco per day Absolute neutrophil count of less than 2500/mm3 or 2.5 x 109/L Any previous treatment with fostamatinib

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

Sexes Eligible for Study
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All

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Fostamatinib | Drug: fostamatinib<br>* oral tablets, 150mg (3 X 50mg) single dose per period<br>|
| Experimental: 2<br>Rifampicin | Drug: fostamatinib<br>* oral tablets, 150mg (3 X 50mg) single dose per period<br>Drug: rifampicin<br>* oral tablets, 600mg (2 X 300mg) 8 doses over 8 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the pharmacokinetics of R406 in healthy subjects when a single dose of fostamatinib is administered alone and in combination with rifampicin. AUC and Cmax will be measured |  | Period 1: Day 1 to 96 hours post-dose Period 2: Day 6 to 96 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the pharmacokinetics of R406 in healthy subjects when a single dose of fostamatinib is administered alone and in combination with rifampicin. AUC (0-t), terminal half life, and tmax will be measured |  | Period 1: Day 1 to 96 hours post-dose Period 2: Day 6 to 96 hours post-dose | 
| To examine the safety and tolerability of fostamatinib in combination with rifampicin. | Assessments include: Adverse events, laboratory assessments, vital signs, physical examination and 12-lead electrocardiogram. Absolute values and change in baseline for any of these parameters will be reported. | From screening, Day 1 - Day 25, up to follow up visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase 1, healthy volunteers, Rheumatoid arthritis, RA, Fostamatinib, Rifampicin, drug-drug interaction, Pharmacokinetics, Amount of Rifampicin in blood