| A Study in Normal Healthy People, Testing Different Versions of a Pill That Will be Used to Treat Rheumatoid Arthritis. |
| 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 |
| 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. |
| Not Provided |
| Interventional |
| Phase 1 |
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label) |
- Rheumatoid Arthritis
- Healthy Volunteers
|
- Drug: CE-224,535
one 250mg tablet, once in the morning in fasted state
Other Name: Part 1;Treatment A
- Drug: CE-224,535
2x250 mg tablets, once in the morning, in fasted state
Other Name: Part 1;Treatment B
- Drug: CE-224,535
4x250mg tablets, once in the morning, in fasted state
Other Name: Part 1;Treatment C
- Drug: CE-224,535
2x250mg tab, once in the morning, after being fed a high fat meal
Other Name: Part 1;Treatment D
- 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 Name: Part 2;Treatment E
- Drug: CE-224,535
4x125 mg IR once in the morning after being fed a high fat meal
Other Name: Part 2; Treatment F
- Drug: CE 224,535
2x250 mg controlled release formulation 5 tabs once in the morning in the fasted state
Other Name: Part 2; Treatment G
- Drug: CE 224,535
2x250 mg controlled release formulation 5 once in the morning after being fed a high fat meal
Other Name: Part 2; Treatment H
|
- Experimental: Part1; controlled release formulation 4; 250 mg
one 250 mg controlled release tablet, once in the morning, in fasted state
Intervention: Drug: CE-224,535
- Experimental: Part1; controlled release formulation 4; 500 mg
2x250 mg, once in the morning, in fasted state
Intervention: Drug: CE-224,535
- Experimental: Part 1; controlled release formula 4; 1000 mg
4x250 mg tabs, once in the morning, in fasted state
Intervention: Drug: CE-224,535
- Experimental: Part 1; controlled release formulation 4; 500 mg FED
2x250 mg, once in the morning , in fed state
Intervention: Drug: CE-224,535
- 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
Intervention: Drug: CE-224,535
- 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.
Intervention: Drug: CE-224,535
- 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.
Intervention: Drug: CE 224,535
- 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
Intervention: Drug: CE 224,535
|
| Not Provided |
| |
| Completed |
| 11 |
| March 2009 |
| March 2009 (Final data collection date for primary outcome measure) |
|
Inclusion Criteria:
Exclusion Criteria:
- severe chronic or uncontrolled medical or psychiatric conditions, including drug abuse
- pregnant or wanting to become pregnant
|
| Sexes Eligible for Study: |
All |
|
| 18 Years to 55 Years (Adult) |
| Yes |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| |
| NCT00838058 |
| A6341012 |
| No |
| Not Provided |
| Not Provided |
| Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| Pfizer |
| Not Provided |
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
| Pfizer |
| October 2009 |
