A Study in Normal Healthy People, Testing Different Versions of a Pill That Will be Used to Treat Rheumatoid Arthritis.
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Part1; controlled release formulation 4; 250 mg one 250 mg controlled release tablet, once in the morning, in fasted state |
Drug: CE-224,535
one 250mg tablet, once in the morning in fasted state
Other Names:
|
| Experimental: Part1; controlled release formulation 4; 500 mg 2x250 mg, once in the morning, in fasted state |
Drug: CE-224,535
2x250 mg tablets, once in the morning, in fasted state
Other Names:
|
| Experimental: Part 1; controlled release formula 4; 1000 mg 4x250 mg tabs, once in the morning, in fasted state |
Drug: CE-224,535
4x250mg tablets, once in the morning, in fasted state
Other Names:
|
| Experimental: Part 1; controlled release formulation 4; 500 mg FED 2x250 mg, once in the morning , in fed state |
Drug: CE-224,535
2x250mg tab, once in the morning, after being fed a high fat meal
Other Names:
|
| Experimental: Part 2; IR formulation 500mg 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
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.
Other Names:
|
| Experimental: Part 2; IR formulation, 500 mg FED 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
4x125 mg IR once in the morning after being fed a high fat meal
Other Names:
|
| Experimental: Part 2; controlled release formulation 5;500 mg, FASTED 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
2x250 mg controlled release formulation 5 tabs once in the morning in the fasted state
Other Names:
|
| Experimental: Part 2; controlled release formulation 5;500 mg, FED 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
2x250 mg controlled release formulation 5 once in the morning after being fed a high fat meal
Other Names:
|
Outcome Measures
Primary Outcome Measures
- pharmacokinetic parameters: Tmax, Cmax, AUClast, AUC(0-00), C24, t1/2 [48 hrs]
Secondary Outcome Measures
- safety parameters including: renal and liver function, blood counts, electrolytes, ECG, and pregnancy testing [48 hrs]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer Investigational Site | New Haven | Connecticut | United States | 06511 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- A6341012