A Study in Normal Healthy People, Testing Different Versions of a Pill That Will be Used to Treat Rheumatoid Arthritis.
October 10, 2009 updated by: Pfizer
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06511
- Pfizer Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Part1; controlled release formulation 4; 250 mg
one 250 mg controlled release tablet, once in the morning, in fasted state
|
one 250mg tablet, once in the morning in fasted state
Other Names:
2x250 mg tablets, once in the morning, in fasted state
Other Names:
4x250mg tablets, once in the morning, in fasted state
Other Names:
2x250mg tab, once in the morning, after being fed a high fat meal
Other Names:
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:
4x125 mg IR once in the morning after being fed a high fat meal
Other Names:
|
|
Experimental: Part1; controlled release formulation 4; 500 mg
2x250 mg, once in the morning, in fasted state
|
one 250mg tablet, once in the morning in fasted state
Other Names:
2x250 mg tablets, once in the morning, in fasted state
Other Names:
4x250mg tablets, once in the morning, in fasted state
Other Names:
2x250mg tab, once in the morning, after being fed a high fat meal
Other Names:
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:
4x125 mg IR once in the morning after being fed a high fat meal
Other Names:
|
|
Experimental: Part 1; controlled release formula 4; 1000 mg
4x250 mg tabs, once in the morning, in fasted state
|
one 250mg tablet, once in the morning in fasted state
Other Names:
2x250 mg tablets, once in the morning, in fasted state
Other Names:
4x250mg tablets, once in the morning, in fasted state
Other Names:
2x250mg tab, once in the morning, after being fed a high fat meal
Other Names:
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:
4x125 mg IR once in the morning after being fed a high fat meal
Other Names:
|
|
Experimental: Part 1; controlled release formulation 4; 500 mg FED
2x250 mg, once in the morning , in fed state
|
one 250mg tablet, once in the morning in fasted state
Other Names:
2x250 mg tablets, once in the morning, in fasted state
Other Names:
4x250mg tablets, once in the morning, in fasted state
Other Names:
2x250mg tab, once in the morning, after being fed a high fat meal
Other Names:
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:
4x125 mg IR 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
|
one 250mg tablet, once in the morning in fasted state
Other Names:
2x250 mg tablets, once in the morning, in fasted state
Other Names:
4x250mg tablets, once in the morning, in fasted state
Other Names:
2x250mg tab, once in the morning, after being fed a high fat meal
Other Names:
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:
4x125 mg IR once in the morning after being fed a high fat meal
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.
|
one 250mg tablet, once in the morning in fasted state
Other Names:
2x250 mg tablets, once in the morning, in fasted state
Other Names:
4x250mg tablets, once in the morning, in fasted state
Other Names:
2x250mg tab, once in the morning, after being fed a high fat meal
Other Names:
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:
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.
|
2x250 mg controlled release formulation 5 tabs once in the morning in the fasted state
Other Names:
2x250 mg controlled release formulation 5 once in the morning after being fed a high fat meal
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
|
2x250 mg controlled release formulation 5 tabs once in the morning in the fasted state
Other Names:
2x250 mg controlled release formulation 5 once in the morning after being fed a high fat meal
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
pharmacokinetic parameters: Tmax, Cmax, AUClast, AUC(0-00), C24, t1/2
Time Frame: 48 hrs
|
48 hrs
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
safety parameters including: renal and liver function, blood counts, electrolytes, ECG, and pregnancy testing
Time Frame: 48 hrs
|
48 hrs
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (Actual)
March 1, 2009
Study Completion (Actual)
March 1, 2009
Study Registration Dates
First Submitted
February 2, 2009
First Submitted That Met QC Criteria
February 5, 2009
First Posted (Estimate)
February 6, 2009
Study Record Updates
Last Update Posted (Estimate)
October 14, 2009
Last Update Submitted That Met QC Criteria
October 10, 2009
Last Verified
October 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A6341012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.