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This study is to test the idea that a controlled release formulation of CE-224,535 may allow for less frequent dosing and exposure to lower levels of drug than an immediate release formulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 50 mg oral suspension | Experimental | once daily for one day |
|
| 50 mg CR Type 1 | Experimental | once daily for one day |
|
| 50 mg CR Type 2 | Experimental | once daily for one day |
|
| 50 mg SR Type 3 | Experimental | once daily for one day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| suspension IR | Drug | 50 mg IR suspension once daily for one day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Various standard descriptive pharmacokinetics endpoints including: Cmin, Cmax, Tmax, AUC. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Safety laboratory testing including: blood electrolytes and liver and kidney function-related chemistries, complete blood counts, urinalysis, and electrocardiogram | 1 month | |
| Other safety parameters including: physical examination and vital signs. | 1 month |
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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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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| CR 1 |
| Drug |
50 mg shorter release CR once daily for one day |
|
| CR 2 | Drug | 50 mg medium release CR once daily for one day |
|
| CR 3 | Drug | longer release SR formulation once daily for one day |
|
| Adverse Event Reporting as reported by subject and through investigator query and categorized by MedRA terminology. | 1 month |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |