A Study in Normal Healthy People, Testing Different Versions of a Pill That Will be Used to Treat Rheumatoid Arthritis.
NCT00838058
Last updated date
ABOUT THIS STUDY
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 Location
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
Rheumatoid Arthritis, Healthy Volunteers
Sex
Females and Males
Age
18-55 years
Inclusion Criteria
Show details
- aged 18-55 and healthy
Exclusion Criteria
Show details
- severe chronic or uncontrolled medical or psychiatric conditions, including drug abuse
- pregnant or wanting to become pregnant
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Rheumatoid Arthritis, Healthy VolunteersA Study in Normal Healthy People, Testing Different Versions of a Pill That Will be Used to Treat Rheumatoid Arthritis.
NCT00838058
- New Haven, Connecticut
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information | ||||
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Brief Title ICMJE | A Study in Normal Healthy People, Testing Different Versions of a Pill That Will be Used to Treat Rheumatoid Arthritis. | |||
Official Title ICMJE | 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 | |||
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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) | |||
Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 11 | |||
Original Estimated Enrollment ICMJE | 24 | |||
Actual Study Completion Date ICMJE | March 2009 | |||
Actual Primary Completion Date | March 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 55 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00838058 | |||
Other Study ID Numbers ICMJE | A6341012 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | October 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |