A Study To Estimate The Amount Of CP-690,550 (Study Drug) That Is Absorbed Into The Blood Of Healthy Subjects Following Oral Administration Of CP-690,550 In Tablet Form

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase 1, Open Label, Single Dose, Randomized, Cross Over Study To Estimate The Absolute Oral Bioavailability Of CP-690,550 In Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Tasocitinib 10 mg oral tablet
* Drug: Tasocitinib 10 mg IV Infusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and/or female (non childbearing potential) Subjects between the ages of 21 and 55 years, inclusive Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs) No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB) 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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A: Tasocitinib 10 mg oral tablet<br> | Drug: Tasocitinib 10 mg oral tablet<br>* Treatment A: Single-dose of tasocitinib (CP-690,550) (10 mg) in the form of an oral tablet<br>|
| Experimental: Treatment B: Tasocitinib 10 mg IV Infusion<br> | Drug: Tasocitinib 10 mg IV Infusion<br>* Treatment B: Single-dose of tasocitinib (CP-690,550) (10 mg) in the form of a 30 minute intravenous infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf of tasocitinib (CP 690,550) |  | PK blood samples out to 12 hours post dose | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| Vital Signs: Blood pressure, heart rate, oral temperature |  | Vital signs out to 2 days post last dose | 
| AE Reporting |  | Throughout study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Absolute Bioavailability, Rheumatoid Arthritis