A Study To Compare The Amount Of Tasocitinib (CP-690,550) That Is Absorbed Into The Blood Of Healthy Subjects Following Oral Administration Of Three Different Tablet Versions Of Tasocitinib (CP-690,550)

Study Overview
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Brief Summary
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In this study, a 10 mg dose of tasocitinib (CP-690,550) will be given to study subjects on three separate occasions using one of three different tablet formulations (tablet versions) each time. The amount of tasocitinib (CP-690,550) available in the blood following administration of each tablet formulation will be measured and compared. The overall aim of the study is to establish that a similar amount of tasocitinib (CP-690,550) is absorbed into the blood following administration of the same dose of each different tablet formulation.

Detailed Description
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This is a pivotal bioequivalence study for tasocitinib (CP-690,550).

Official Title
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Phase 1, Open-Label, Randomized, Single-Dose, 3-Treatment, 3-Period, Cross-Over, Bioequivalence Study Comparing Phase 2b, Phase 3 And Commercial Image Tablet Formulations Of Tasocitinib (CP-690,550) Under Fasted Conditions

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: Treatment A
* Drug: Treatment B
* Drug: Treatment C
* Drug: Treatment A
* Drug: Treatment C
* Drug: Treatment B
* Drug: Treatment B
* Drug: Treatment C
* Drug: Treatment A
* Drug: Treatment B
* Drug: Treatment A
* Drug: Treatment C
* Drug: Treatment C
* Drug: Treatment A
* Drug: Treatment B
* Drug: Treatment C
* 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 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 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 10 mg tasocitinib citrate (CP-690,550-10)administered as one 10 mg immediate release tablet (ICH -commercial image tablet).<br>Drug: Treatment B<br>* Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg immediate release filmcoated tablets (Phase 3 tablets).<br>Drug: Treatment C<br>* Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg tablets (Phase 2B tablets).<br>|
| Experimental: Sequence 2<br> | Drug: Treatment A<br>* Single oral dose of 10 mg tasocitinib citrate (CP-690,550-10)administered as one 10 mg immediate release tablet (ICH -commercial image tablet).<br>Drug: Treatment C<br>* Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg tablets (Phase 2B tablets).<br>Drug: Treatment B<br>* Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg immediate release filmcoated tablets (Phase 3 tablets).<br>|
| Experimental: Sequence 3<br> | Drug: Treatment B<br>* Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg immediate release filmcoated tablets (Phase 3 tablets).<br>Drug: Treatment C<br>* Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg tablets (Phase 2B tablets).<br>Drug: Treatment A<br>* Single oral dose of 10 mg tasocitinib citrate (CP-690,550-10)administered as one 10 mg immediate release tablet (ICH -commercial image tablet).<br>|
| Experimental: Sequence 4<br> | Drug: Treatment B<br>* Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg immediate release filmcoated tablets (Phase 3 tablets).<br>Drug: Treatment A<br>* Single oral dose of 10 mg tasocitinib citrate (CP-690,550-10)administered as one 10 mg immediate release tablet (ICH -commercial image tablet).<br>Drug: Treatment C<br>* Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg tablets (Phase 2B tablets).<br>|
| Experimental: Sequence 5<br> | Drug: Treatment C<br>* Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg tablets (Phase 2B tablets).<br>Drug: Treatment A<br>* Single oral dose of 10 mg tasocitinib citrate (CP-690,550-10)administered as one 10 mg immediate release tablet (ICH -commercial image tablet).<br>Drug: Treatment B<br>* Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg immediate release filmcoated tablets (Phase 3 tablets).<br>|
| Experimental: Sequence 6<br> | Drug: Treatment C<br>* Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg tablets (Phase 2B tablets).<br>Drug: Treatment B<br>* Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg immediate release filmcoated tablets (Phase 3 tablets).<br>Drug: Treatment A<br>* Single oral dose of 10 mg tasocitinib citrate (CP-690,550-10)administered as one 10 mg immediate release tablet (ICH -commercial image tablet).<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 tasocitinib (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, t½ of tasocitinib (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 Period 3. | 
| Safety: vital signs |  | Prior to dosing in each period and at 24 hours post last dose in Period 3. | 
| 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