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

NCT ID: NCT00838058

Last Updated: 2009-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2009-03-31

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.

Conditions

Rheumatoid Arthritis; Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

Part1; controlled release formulation 4; 250 mg

one 250 mg controlled release tablet, once in the morning, in fasted state

Group Type: EXPERIMENTAL

CE-224,535

Intervention Type: DRUG

one 250mg tablet, once in the morning in fasted state

Part1; controlled release formulation 4; 500 mg

2x250 mg, once in the morning, in fasted state

Group Type: EXPERIMENTAL

CE-224,535

Intervention Type: DRUG

2x250 mg tablets, once in the morning, in fasted state

Part 1; controlled release formula 4; 1000 mg

4x250 mg tabs, once in the morning, in fasted state

Group Type: EXPERIMENTAL

CE-224,535

Intervention Type: DRUG

4x250mg tablets, once in the morning, in fasted state

Part 1; controlled release formulation 4; 500 mg FED

2x250 mg, once in the morning , in fed state

Group Type: EXPERIMENTAL

CE-224,535

Intervention Type: DRUG

2x250mg tab, once in the morning, after being fed a high fat meal

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

Group Type: EXPERIMENTAL

CE-224,535

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

CE-224,535

Intervention Type: DRUG

4x125 mg IR once in the morning after being fed a high fat meal

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.

Group Type: EXPERIMENTAL

CE 224,535

Intervention Type: DRUG

2x250 mg controlled release formulation 5 tabs once in the morning in the fasted state

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

Group Type: EXPERIMENTAL

CE 224,535

Intervention Type: DRUG

2x250 mg controlled release formulation 5 once in the morning after being fed a high fat meal

Interventions

CE-224,535

one 250mg tablet, once in the morning in fasted state

Intervention Type: DRUG

CE-224,535

2x250 mg tablets, once in the morning, in fasted state

Intervention Type: DRUG

CE-224,535

4x250mg tablets, once in the morning, in fasted state

Intervention Type: DRUG

CE-224,535

2x250mg tab, once in the morning, after being fed a high fat meal

Intervention Type: 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.

Intervention Type: DRUG

CE-224,535

4x125 mg IR once in the morning after being fed a high fat meal

Intervention Type: DRUG

CE 224,535

2x250 mg controlled release formulation 5 tabs once in the morning in the fasted state

Intervention Type: DRUG

CE 224,535

2x250 mg controlled release formulation 5 once in the morning after being fed a high fat meal

Intervention Type: DRUG

Other Intervention Names

Part 1;Treatment A; Part 1;Treatment B; Part 1;Treatment C; Part 1;Treatment D; Part 2;Treatment E; Part 2; Treatment F; Part 2; Treatment G; Part 2; Treatment H

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Pfizer, Inc.

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Pfizer Investigational Site

New Haven, Connecticut, United States

Countries

United States

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6341012&StudyName=A%20study%20in%20normal%20healthy%20people%2C%20testing%20different%20versions%20of%20a%20pill%20that%20will%20be%20used%20to%20treat%20rheumatoid%20arthritis.

To obtain contact information for a study center near you, click here.

Other Identifiers

A6341012

Identifier Type: -

Identifier Source: org_study_id