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

October 10, 2009 updated by: Pfizer

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
11

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • Part 1;Treatment A
Drug: CE-224,535
2x250 mg tablets, once in the morning, in fasted state
Other Names:
  • Part 1;Treatment B
Drug: CE-224,535
4x250mg tablets, once in the morning, in fasted state
Other Names:
  • Part 1;Treatment C
Drug: CE-224,535
2x250mg tab, once in the morning, after being fed a high fat meal
Other Names:
  • 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 Names:
  • Part 2;Treatment E
Drug: CE-224,535
4x125 mg IR once in the morning after being fed a high fat meal
Other Names:
  • Part 2; Treatment F
Experimental: Part1; controlled release formulation 4; 500 mg
2x250 mg, once in the morning, in fasted state
Drug: CE-224,535
one 250mg tablet, once in the morning in fasted state
Other Names:
  • Part 1;Treatment A
Drug: CE-224,535
2x250 mg tablets, once in the morning, in fasted state
Other Names:
  • Part 1;Treatment B
Drug: CE-224,535
4x250mg tablets, once in the morning, in fasted state
Other Names:
  • Part 1;Treatment C
Drug: CE-224,535
2x250mg tab, once in the morning, after being fed a high fat meal
Other Names:
  • 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 Names:
  • Part 2;Treatment E
Drug: CE-224,535
4x125 mg IR once in the morning after being fed a high fat meal
Other Names:
  • Part 2; Treatment F
Experimental: Part 1; controlled release formula 4; 1000 mg
4x250 mg tabs, once in the morning, in fasted state
Drug: CE-224,535
one 250mg tablet, once in the morning in fasted state
Other Names:
  • Part 1;Treatment A
Drug: CE-224,535
2x250 mg tablets, once in the morning, in fasted state
Other Names:
  • Part 1;Treatment B
Drug: CE-224,535
4x250mg tablets, once in the morning, in fasted state
Other Names:
  • Part 1;Treatment C
Drug: CE-224,535
2x250mg tab, once in the morning, after being fed a high fat meal
Other Names:
  • 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 Names:
  • Part 2;Treatment E
Drug: CE-224,535
4x125 mg IR once in the morning after being fed a high fat meal
Other Names:
  • Part 2; Treatment F
Experimental: Part 1; controlled release formulation 4; 500 mg FED
2x250 mg, once in the morning , in fed state
Drug: CE-224,535
one 250mg tablet, once in the morning in fasted state
Other Names:
  • Part 1;Treatment A
Drug: CE-224,535
2x250 mg tablets, once in the morning, in fasted state
Other Names:
  • Part 1;Treatment B
Drug: CE-224,535
4x250mg tablets, once in the morning, in fasted state
Other Names:
  • Part 1;Treatment C
Drug: CE-224,535
2x250mg tab, once in the morning, after being fed a high fat meal
Other Names:
  • 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 Names:
  • Part 2;Treatment E
Drug: CE-224,535
4x125 mg IR once in the morning after being fed a high fat meal
Other Names:
  • Part 2; Treatment F
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
one 250mg tablet, once in the morning in fasted state
Other Names:
  • Part 1;Treatment A
Drug: CE-224,535
2x250 mg tablets, once in the morning, in fasted state
Other Names:
  • Part 1;Treatment B
Drug: CE-224,535
4x250mg tablets, once in the morning, in fasted state
Other Names:
  • Part 1;Treatment C
Drug: CE-224,535
2x250mg tab, once in the morning, after being fed a high fat meal
Other Names:
  • 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 Names:
  • Part 2;Treatment E
Drug: CE-224,535
4x125 mg IR once in the morning after being fed a high fat meal
Other Names:
  • Part 2; Treatment F
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
one 250mg tablet, once in the morning in fasted state
Other Names:
  • Part 1;Treatment A
Drug: CE-224,535
2x250 mg tablets, once in the morning, in fasted state
Other Names:
  • Part 1;Treatment B
Drug: CE-224,535
4x250mg tablets, once in the morning, in fasted state
Other Names:
  • Part 1;Treatment C
Drug: CE-224,535
2x250mg tab, once in the morning, after being fed a high fat meal
Other Names:
  • 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 Names:
  • Part 2;Treatment E
Drug: CE-224,535
4x125 mg IR once in the morning after being fed a high fat meal
Other Names:
  • 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 Names:
  • 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 Names:
  • Part 2; Treatment H
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 tabs once in the morning in the fasted state
Other Names:
  • 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 Names:
  • Part 2; Treatment H

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
pharmacokinetic parameters: Tmax, Cmax, AUClast, AUC(0-00), C24, t1/2
Time Frame: 48 hrs
48 hrs

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
safety parameters including: renal and liver function, blood counts, electrolytes, ECG, and pregnancy testing
Time Frame: 48 hrs
48 hrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 2, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 6, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 14, 2009

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2009

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A6341012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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