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In this study, a 10 mg dose of CP-690,550 will be given to study subjects on two separate occasions by two different routes of administration: One time by mouth in tablet form and one time by vein (intravenous form). The amount of CP-690,550 available in the blood following administration by vein will be measured and is expected to reflect the maximum amount possible for the 10 mg CP-690,550 dose. The amount of CP-690,550 that is achieved in the blood following oral tablet administration will also be measured and compared to that achieved following administration by vein in order to estimate how much of the maximum amount possible is actually absorbed into the blood following administration by mouth as a tablet.
To estimate the absolute bioavailability of a 10 mg oral dose of tasocitinib (CP-690,550) compared to a 10 mg intravenous dose of tasocitinib (CP-690,550) in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A: Tasocitinib 10 mg oral tablet | Experimental |
| |
| Treatment B: Tasocitinib 10 mg IV Infusion | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tasocitinib 10 mg oral tablet | Drug | Treatment A: Single-dose of tasocitinib (CP-690,550) (10 mg) in the form of an oral tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUCinf of tasocitinib (CP 690,550) | PK blood samples out to 12 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| AUClast, Cmax, Tmax, and t½, CL (IV dose only) and Vss (IV dose only) of tasocitinib (CP 690,550). | PK blood samples out to 12 hours postdose | |
| Safety Laboratory tests: hematology, chemistry, urine testing | Safety Laboratory testing performed out to 2 days post last dose |
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Inclusion Criteria:
Exclusion Criteria:
Evidence or history of any clinically significant illness, medical condition, or disease.
2. Evidence or history of any clinically significant infections within the past 3 months.
3. Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
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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 | Singapore | 188770 | Singapore |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Tasocitinib 10 mg IV Infusion | Drug | Treatment B: Single-dose of tasocitinib (CP-690,550) (10 mg) in the form of a 30 minute intravenous infusion |
|
| Vital Signs: Blood pressure, heart rate, oral temperature | Vital signs out to 2 days post last dose |
| AE Reporting | Throughout study |
| 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 |
|---|---|
| C479163 | tofacitinib |
| D013607 | Tablets |
| D007262 | Infusions, Intravenous |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D061605 | Administration, Intravenous |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D007263 | Infusions, Parenteral |
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