A Study To Compare The Amount Of CP-690,550 That Is Absorbed Into The Blood Of Healthy Subjects Following Oral Administration Of Two Different Strength Tablets Of CP-690,550

Study Overview
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Brief Summary
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In this study, a 5 mg dose of CP-690,550 will be given to study subjects on two separate occasions using one of two different strength tablets each time. The amount of CP-690,550 available in the blood following administration of each tablet will be measured and compared. The overall aim of the study is to establish that a similar amount of CP-690,550 is absorbed into the blood following administration of the same dose of each different strength tablet .

Detailed Description
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This is a bioequivalence study for CP-690,550.

Official Title
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Phase 1, Open-label, Randomized, Single-dose, 2-treatment, 2-period, Crossover, Bioequivalence Study Comparing Phase 2b 1 Mg And 5 Mg Tablet Formulations Of Cp-690,550 Under Fasted Conditions

Conditions
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Arthritis, Rheumatoid

Intervention / Treatment
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* Drug: Treatment A
* Drug: Treatment B
* Drug: Treatment B
* Drug: Treatment A


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 >45 kg (99 lbs). No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB). Exclusion Criteria: Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing). Personal or family history of hereditary immunodeficiency (eg, severe - Evidence of any clinically significant illness, medical condition, or disease. Evidence or history of any clinically significant infections within the past 3 months. 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: Sequence 1<br> | Drug: Treatment A<br>* Single oral dose of 5 mg CP-690,550 administered as five 1 mg tablets (Phase 2B tablets)<br>Drug: Treatment B<br>* Single oral dose of 5 mg CP-690,550 administered as one 5 mg tablet (Phase 2B tablet)<br>|
| Experimental: Sequence 2<br> | Drug: Treatment B<br>* Single oral dose of 5 mg CP-690,550 administered as one 5 mg tablet (Phase 2B tablet)<br>Drug: Treatment A<br>* Single oral dose of 5 mg CP-690,550 administered as five 1 mg tablets (Phase 2B tablets)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK parameters: AUCinf, AUClast and Cmax of CP-690,550 |  | PK blood samples out to 24 hours post dose in each period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK parameters: Tmax, AUCt and half-life of CP-690,550 |  | Derived from PK blood samples out to 24 hours post dose in each period | 
| Safety: laboratory tests |  | Pre-dose on Day 0 for Period 1 and at 24 hours post last dose in each period | 
| Safety: vital signs |  | Prior to dosing in each period and at 24 hours post last dose in Period 2 | 
| Safety: adverse event reporting |  | Throughout study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioequivalence, healthy volunteer study, Rheumatoid Arthritis