A Study in Normal Healthy People, Testing Different Versions of a Pill That Will be Used to Treat Rheumatoid Arthritis.

Study Overview
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Brief Summary
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The study will try, in 2 separate parts, each using 12 research subjects, to see how a new form of the pill CE 224,535 gets released into the bloodstream and whether that is affected by food. In each part, subjects will switch among 4 treatment periods to take either different forms of the pill(s) or the same form either after fasting or eating a meal. The second part will only happen depending on whether the sponsor believes it is needed and will use separate subject than the first part.

Official Title
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An Open-Label Two-Part Randomized, Crossover Study Of The Pharmacokinetics Of CE-224,535 Administered As Controlled And Immediate Release Formulations In Healthy Volunteers

Conditions
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Rheumatoid Arthritis, Healthy Volunteers

Intervention / Treatment
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* Drug: CE-224,535
* Drug: CE-224,535
* Drug: CE-224,535
* Drug: CE-224,535
* Drug: CE-224,535
* Drug: CE-224,535
* Drug: CE 224,535
* Drug: CE 224,535


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged 18-55 and healthy Exclusion Criteria: severe chronic or uncontrolled medical or psychiatric conditions, including drug abuse pregnant or wanting to become pregnant

Ages Eligible for Study
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Minimum Age: 18 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: Part1; controlled release formulation 4; 250 mg<br>one 250 mg controlled release tablet, once in the morning, in fasted state | Drug: CE-224,535<br>* one 250mg tablet, once in the morning in fasted state<br>* Other names: Part 1;Treatment A;|
| Experimental: Part1; controlled release formulation 4; 500 mg<br>2x250 mg, once in the morning, in fasted state | Drug: CE-224,535<br>* 2x250 mg tablets, once in the morning, in fasted state<br>* Other names: Part 1;Treatment B;|
| Experimental: Part 1; controlled release formula 4; 1000 mg<br>4x250 mg tabs, once in the morning, in fasted state | Drug: CE-224,535<br>* 4x250mg tablets, once in the morning, in fasted state<br>* Other names: Part 1;Treatment C;|
| Experimental: Part 1; controlled release formulation 4; 500 mg FED<br>2x250 mg, once in the morning , in fed state | Drug: CE-224,535<br>* 2x250mg tab, once in the morning, after being fed a high fat meal<br>* Other names: Part 1;Treatment D;|
| Experimental: Part 2; IR formulation 500mg<br>4x125 mg tab of current formulation , once in the morning in the fasted state. This arm will occur as Part 2, only as needed, pending results of Part 1 | Drug: CE-224,535<br>* 4x125 mg tabs, once in the morning, in the fasted state. This arm will only occur as part of Part 2, if needed, pending results of Part 1.<br>* Other names: Part 2;Treatment E;|
| Experimental: Part 2; IR formulation, 500 mg FED<br>4x125 mg once in the morning in the fed state. This arm will occur as part of Part 2,only as needed, pending results of Part 1. | Drug: CE-224,535<br>* 4x125 mg IR once in the morning after being fed a high fat meal<br>* Other names: Part 2; Treatment F;|
| Experimental: Part 2; controlled release formulation 5;500 mg, FASTED<br>2x250 controlled release formulation 5 tabs once in the morning in the fasted state. This arm will only occur as part of Part 2, pending results of Part 1. | Drug: CE 224,535<br>* 2x250 mg controlled release formulation 5 tabs once in the morning in the fasted state<br>* Other names: Part 2; Treatment G;|
| Experimental: Part 2; controlled release formulation 5;500 mg, FED<br>2x250 mg controlled release formulation 5 tabs once in the morning in the fed state. This arm will only occur as part of Part 2 pending results of Part 1 | Drug: CE 224,535<br>* 2x250 mg controlled release formulation 5 once in the morning after being fed a high fat meal<br>* Other names: Part 2; Treatment H;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pharmacokinetic parameters: Tmax, Cmax, AUClast, AUC(0-00), C24, t1/2 |  | 48 hrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety parameters including: renal and liver function, blood counts, electrolytes, ECG, and pregnancy testing |  | 48 hrs | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pharmacology formulation normal healthy volunteers food effect