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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00838058
First received: February 2, 2009
Last updated: October 10, 2009
Last verified: October 2009
History of Changes

February 2, 2009
October 10, 2009
January 2009
March 2009   (final data collection date for primary outcome measure)
pharmacokinetic parameters: Tmax, Cmax, AUClast, AUC(0-00), C24, t1/2 [ Time Frame: 48 hrs ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00838058 on ClinicalTrials.gov Archive Site
safety parameters including: renal and liver function, blood counts, electrolytes, ECG, and pregnancy testing [ Time Frame: 48 hrs ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
11
March 2009
March 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00838058
A6341012
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP