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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pioglitazone | Experimental |
| |
| pioglitazone and fostamatinib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fostamatinib | Drug | oral tablets, 100mg (2 X 50mg) twice daily for 8 days |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Layton, MD, MRCP | AstraZeneca | Study Director |
| Carlos Prendes, MD | Quintiles Overland Park, Phase 1 Unit | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Overland Park | Kansas | United States |
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| pioglitazone |
| Drug |
oral tablets, 30mg single dose per period |
|
| 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) |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C523665 | fostamatinib |
| D000077205 | Pioglitazone |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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