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The study will try, in 2 separate parts, each using 12 research subjects, to see how a new form of the pill CE 224,535 gets released into the bloodstream and whether that is affected by food. In each part, subjects will switch among 4 treatment periods to take either different forms of the pill(s) or the same form either after fasting or eating a meal. The second part will only happen depending on whether the sponsor believes it is needed and will use separate subject than the first part.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part1; controlled release formulation 4; 250 mg | Experimental | one 250 mg controlled release tablet, once in the morning, in fasted state |
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| Part1; controlled release formulation 4; 500 mg | Experimental | 2x250 mg, once in the morning, in fasted state |
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| Part 1; controlled release formula 4; 1000 mg | Experimental | 4x250 mg tabs, once in the morning, in fasted state |
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| Part 1; controlled release formulation 4; 500 mg FED | Experimental | 2x250 mg, once in the morning , in fed state |
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| Part 2; IR formulation 500mg | Experimental | 4x125 mg tab of current formulation , once in the morning in the fasted state. This arm will occur as Part 2, only as needed, pending results of Part 1 |
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| Part 2; IR formulation, 500 mg FED |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CE-224,535 | Drug | one 250mg tablet, once in the morning in fasted state |
|
| Measure | Description | Time Frame |
|---|---|---|
| pharmacokinetic parameters: Tmax, Cmax, AUClast, AUC(0-00), C24, t1/2 | 48 hrs |
| Measure | Description | Time Frame |
|---|---|---|
| safety parameters including: renal and liver function, blood counts, electrolytes, ECG, and pregnancy testing | 48 hrs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | New Haven | Connecticut | 06511 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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4x125 mg once in the morning in the fed state. This arm will occur as part of Part 2,only as needed, pending results of Part 1. |
|
| Part 2; controlled release formulation 5;500 mg, FASTED | Experimental | 2x250 controlled release formulation 5 tabs once in the morning in the fasted state. This arm will only occur as part of Part 2, pending results of Part 1. |
|
| Part 2; controlled release formulation 5;500 mg, FED | Experimental | 2x250 mg controlled release formulation 5 tabs once in the morning in the fed state. This arm will only occur as part of Part 2 pending results of Part 1 |
|
| CE-224,535 | Drug | 2x250 mg tablets, once in the morning, in fasted state |
|
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| CE-224,535 | Drug | 4x250mg tablets, once in the morning, in fasted state |
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| CE-224,535 | Drug | 2x250mg tab, once in the morning, after being fed a high fat meal |
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| CE-224,535 | Drug | 4x125 mg tabs, once in the morning, in the fasted state. This arm will only occur as part of Part 2, if needed, pending results of Part 1. |
|
|
| CE-224,535 | Drug | 4x125 mg IR once in the morning after being fed a high fat meal |
|
|
| CE 224,535 | Drug | 2x250 mg controlled release formulation 5 tabs once in the morning in the fasted state |
|
|
| CE 224,535 | Drug | 2x250 mg controlled release formulation 5 once in the morning after being fed a high fat meal |
|
|
| 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 |
|---|---|
| C562356 | CE 224,535 |
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