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OpenTrials
Completed

NCT Number: NCT00838058

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

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Healthy Volunteers Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CE-224,535

Drug

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

Other names: Part 1;Treatment A

CE 224,535

Drug

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

Other names: Part 2; Treatment G

Primary outcomes

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

    Time frame: 48 hrs

Secondary outcomes

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

    Time frame: 48 hrs

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Feb 6, 2009
Registry last updated
Oct 14, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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