NCT00838058

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_1 rheumatoid-arthritis

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_1 rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 2, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 6, 2009

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

October 14, 2009

Status Verified

October 1, 2009

Enrollment Period

2 months

First QC Date

February 2, 2009

Last Update Submit

October 10, 2009

Conditions

Rheumatoid ArthritisHealthy Volunteers

Keywords

pharmacology formulation normal healthy volunteers food effect

Outcome Measures

Primary Outcomes (1)

  • pharmacokinetic parameters: Tmax, Cmax, AUClast, AUC(0-00), C24, t1/2

    48 hrs

Secondary Outcomes (1)

  • safety parameters including: renal and liver function, blood counts, electrolytes, ECG, and pregnancy testing

    48 hrs

Study Arms (8)

Part1; controlled release formulation 4; 250 mg

EXPERIMENTAL

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

Drug: CE-224,535

Part1; controlled release formulation 4; 500 mg

EXPERIMENTAL

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

Drug: CE-224,535

Part 1; controlled release formula 4; 1000 mg

EXPERIMENTAL

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

Drug: CE-224,535

Part 1; controlled release formulation 4; 500 mg FED

EXPERIMENTAL

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

Drug: CE-224,535

Part 2; IR formulation 500mg

EXPERIMENTAL

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

Part 2; IR formulation, 500 mg FED

EXPERIMENTAL

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

Part 2; controlled release formulation 5;500 mg, FASTED

EXPERIMENTAL

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

Part 2; controlled release formulation 5;500 mg, FED

EXPERIMENTAL

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

Interventions

CE-224,535DRUG

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

Also known as: Part 1;Treatment A
Part1; controlled release formulation 4; 250 mg
CE 224,535DRUG

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

Also known as: Part 2; Treatment G
Part 2; controlled release formulation 5;500 mg, FASTED

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • aged 18-55 and healthy

You may not qualify if:

  • severe chronic or uncontrolled medical or psychiatric conditions, including drug abuse
  • pregnant or wanting to become pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Location

Related Links

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

CE 224,535

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 2, 2009

First Posted

February 6, 2009

Study Start

January 1, 2009

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

October 14, 2009

Record last verified: 2009-10

Locations

US(1)