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
  Purpose

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.


Condition Intervention Phase
Rheumatoid Arthritis
Healthy Volunteers
Drug: CE-224,535
Drug: CE 224,535
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • pharmacokinetic parameters: Tmax, Cmax, AUClast, AUC(0-00), C24, t1/2 [ Time Frame: 48 hrs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • safety parameters including: renal and liver function, blood counts, electrolytes, ECG, and pregnancy testing [ Time Frame: 48 hrs ] [ Designated as safety issue: Yes ]

Enrollment: 11
Study Start Date: January 2009
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part1; controlled release formulation 4; 250 mg
one 250 mg controlled release tablet, once in the morning, in fasted state
Drug: CE-224,535
one 250mg tablet, once in the morning in fasted state
Other Name: Part 1;Treatment A
Experimental: Part1; controlled release formulation 4; 500 mg
2x250 mg, once in the morning, in fasted state
Drug: CE-224,535
2x250 mg tablets, once in the morning, in fasted state
Other Name: Part 1;Treatment B
Experimental: Part 1; controlled release formula 4; 1000 mg
4x250 mg tabs, once in the morning, in fasted state
Drug: CE-224,535
4x250mg tablets, once in the morning, in fasted state
Other Name: Part 1;Treatment C
Experimental: Part 1; controlled release formulation 4; 500 mg FED
2x250 mg, once in the morning , in fed state
Drug: CE-224,535
2x250mg tab, once in the morning, after being fed a high fat meal
Other Name: Part 1;Treatment D
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
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
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.
Drug: CE-224,535
4x125 mg IR once in the morning after being fed a high fat meal
Other Name: Part 2; Treatment F
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.
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
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
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00838058

Locations
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00838058     History of Changes
Other Study ID Numbers: A6341012
Study First Received: February 2, 2009
Last Updated: October 10, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
pharmacology formulation normal healthy volunteers food effect

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 28, 2014