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This study is designed to evaluate how CP-690,550 is handled by the body in healthy volunteers who have mild and moderate hepatic impairment compared to healthy volunteers with normal hepatic function. This study will also evaluate the safety and tolerability of CP-690,550.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal hepatic function | Experimental |
| |
| Mild hepatic impairment | Experimental |
| |
| Moderate hepatic impairment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CP-690,550 | Drug | Single 10 mg dose of CP-690,550 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of CP-690,550 in subjects with hepatic impairment compared to subjects with normal hepatic function | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of CP-690,550 in subjects with hepatic impairment compared to subjects with normal hepatic function | 10-14 days |
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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 | South Miami | Florida | 33143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27129117 | Derived | Lawendy N, Lamba M, Chan G, Wang R, Alvey CW, Krishnaswami S. The effect of mild and moderate hepatic impairment on the pharmacokinetics of tofacitinib, an orally active Janus kinase inhibitor. Clin Pharmacol Drug Dev. 2014 Nov;3(6):421-7. doi: 10.1002/cpdd.143. Epub 2014 Oct 1. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D048550 | Hepatic Insufficiency |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C479163 | tofacitinib |
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| CP-690,550 |
| Drug |
Single 10 mg dose of CP-690,550 |
|
| CP-690,550 | Drug | Single 10 mg dose of CP-690,550 |
|