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

Phase 1

Completed

• Conditions: Rheumatoid Arthritis; Healthy Volunteers
• Interventions: Drug: CE-224,535; Drug: CE 224,535

• Registration Number: NCT00838058
• Lead Sponsor: Pfizer

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 available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-02-02
• Study First Submitted QC: 2009-02-05
• Study First Posted: 2009-02-06
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Status Verified: 2009-10
• Last Update Submitted: 2009-10-10
• Last Update Posted: 2009-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Part1; controlled release formulation 4; 250 mg	CE-224,535	one 250 mg controlled release tablet, once in the morning, in fasted state
Part1; controlled release formulation 4; 500 mg	CE-224,535	2x250 mg, once in the morning, in fasted state
Part 1; controlled release formula 4; 1000 mg	CE-224,535	4x250 mg tabs, once in the morning, in fasted state
Part 1; controlled release formulation 4; 500 mg FED	CE-224,535	2x250 mg, once in the morning , in fed state
Part 2; IR formulation 500mg	CE-224,535	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
Part 2; IR formulation, 500 mg FED	CE-224,535	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.
Part 2; controlled release formulation 5;500 mg, FASTED	CE 224,535	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.
Part 2; controlled release formulation 5;500 mg, FED	CE 224,535	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

Primary Outcome Measures

Name	Time	Method
pharmacokinetic parameters: Tmax, Cmax, AUClast, AUC(0-00), C24, t1/2	48 hrs

Secondary Outcome Measures

Name	Time	Method
safety parameters including: renal and liver function, blood counts, electrolytes, ECG, and pregnancy testing	48 hrs

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 New Haven, Connecticut, United States