Effects of Administration of Fostamatinib on Blood Concentrations of Pioglitazone 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 pioglitazone by comparing the safety, tolerability and plasma concentration of pioglitazone when administered alone and with fostamatinib in healthy subjects.

Official Title
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An Open-Label, Single Center Study to Assess the Pharmacokinetics of Pioglitazone in Healthy Subjects When Administered Alone and in Combination With Fostamatinib 100 mg Twice Daily

Conditions
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Rheumatoid Arthritis, Healthy Volunteers, Pharmacokinetics, Pioglitazone, Drug-drug Interaction, Amount of Pioglitazone in Blood

Intervention / Treatment
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* Drug: fostamatinib
* Drug: pioglitazone


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 (of non-child bearing potential) aged 18 to 55 years (inclusive) Minimum weight of 50 kg and a body mass index (BMI) of 18 to 35 kg/m2 (inclusive) Males must be willing to use barrier contraception ie, condoms, from the first administration until 2 weeks after the last administration of the investigational product Exclusion Criteria: History or presence of gastrointestinal, hepatic or renal disease (except for cholecystectomy) Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of the investigational product 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 or pioglitazone

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: pioglitazone<br> | Drug: fostamatinib<br>* oral tablets, 100mg (2 X 50mg) twice daily for 8 days<br>Drug: pioglitazone<br>* oral tablets, 30mg single dose per period<br>|
| Experimental: pioglitazone and fostamatinib<br> | Drug: pioglitazone<br>* oral tablets, 30mg single dose per period<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess pharmacokinetics (PK) of pioglitazone including but not limited to AUC and Cmax |  | Period 1: Pre-dose to 48h post dose | 
| To assess pharmacokinetics (PK) of pioglitazone including but not limited to AUC and Cmax |  | Period 2: Pre-dose to 48h post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess pharmacokinetics (PK) of hydroxypioglitazone (active metabolite) including but not limited to AUC and Cmax |  | Period 1: Pre-dose to 48h post dose | 
| To assess pharmacokinetics (PK) of hydroxypioglitazone (active metabolite) including but not limited to AUC and Cmax |  | Period 2: Pre-dose to 48h post dose | 
| To examine the safety and tolerability | To examine the safety and tolerability of fostamatinib in combination with pioglitazone. Assessments include: Adverse events, laboratory assessments, vital signs, physical examination and 12-lead electrocardiogram | From screening, Day -1 to Day 9 and follow up visit (Day 16) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase 1, healthy volunteers, pharmacokinetics, Rheumatoid arthritis, RA, fostamatinib, pioglitazone, drug-drug interaction