A Study To Evaluate The Effect Of Food On How Tasocitinib (CP-690,550) Is Absorbed And Moves Through The Body Following Oral Administration Of Tasocitinib (CP-690,550) Tablets To Healthy Subjects

Study Overview
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Brief Summary
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In this study, a 10 mg tasocitinib (CP-690,550) tablet will be administered to healthy subjects on two separate dosing occasions. On one occasion the tasocitinib (CP-690,550) tablet will be administered in a fasting condition; On the other occasion the tasocitinib (CP-690,550) tablet will be administered in a fed condition following a standard breakfast meal. The amount of tasocitinib (CP-690,550) in the blood will be measured at various times over 24 hours following each dosing occasion and compared to evaluate for any differences.

Detailed Description
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To evaluate the effect of food on the pharmacokinetics of tasocitinib (CP-690,550).

Official Title
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A Phase 1, Randomized, 2-Period, 2-Sequence, Open Label, Single Dose, Cross-Over Study To Evaluate The Effect Of Food On Pharmacokinetics Of Tasocitinib (CP-690,550) Tablets In Healthy Subjects

Conditions
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Rheumatoid Arthritis

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. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight for males>50 kg (110 lbs). For females, total body weight >45 kg (99 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. 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 dose of tasocitinib (CP-690,550) 10 mg under fed conditions.<br>Drug: Treatment B<br>* Single dose of tasocitinib (CP-690,550) 10 mg under fasted conditions.<br>|
| Experimental: Sequence 2<br> | Drug: Treatment B<br>* Single dose of tasocitinib (CP-690,550) 10 mg under fasted conditions.<br>Drug: Treatment A<br>* Single dose of tasocitinib (CP-690,550) 10 mg under fed conditions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf and Cmax of tasocitinib (CP-690,550). |  | PK blood samples out to 24 hours post dose in each of two periods. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUClast, Tmax, and t1/2 of tasocitinib (CP-690,550). |  | PK blood samples out to 24 hours post dose in each of two periods. | 
| Safety: Laboratory tests. |  | Pre-dose on Day O of Period 1 and post-dose on Day 2 of Period 2. | 
| Safety:Vital signs. |  | Prior to dosing in Period 1 and 2. | 
| Safety: AE reporting. |  | Continuous | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy subjects, Food Effect Study