MedTrace Logo

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

NCT00838058 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2009-10-14

No results posted yet for this study

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

Interventions

DRUG

CE-224,535

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

DRUG

CE-224,535

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

DRUG

CE-224,535

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

DRUG

CE-224,535

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

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.

DRUG

CE-224,535

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

DRUG

CE 224,535

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

DRUG

CE 224,535

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

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00838058 on ClinicalTrials.gov