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

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NCT00838058

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Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511, United States
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis, Healthy Volunteers
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- aged 18-55 and healthy

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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
  1. New Haven, Connecticut
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
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
  • Rheumatoid Arthritis
  • Healthy Volunteers
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
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
 (submitted: April 3, 2009)		11
Original Estimated Enrollment  ICMJE
 (submitted: February 5, 2009)		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:

  • aged 18-55 and healthy

Exclusion Criteria:

  • severe chronic or uncontrolled medical or psychiatric conditions, including drug abuse
  • pregnant or wanting to become pregnant
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Study Director:Pfizer CT.gov Call CenterPfizer
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