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IR

Phase 1

Rheumatoid Arthritis | Small molecule | Immunology |Pfizer, Inc.|Last Updated: Jun 9, 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

Clinical trial landscape

IR · 1 trial · 1 indication

Phase 1 1
NCT00782600Study of Controlled Release Formulations of CE-224,535 Against the Immediate Release Formulation in Normal VolunteersRheumatoid Arthritis
COMPLETED16 Analytics
PHASE1COMPLETED
Study of Controlled Release Formulations of CE-224,535 Against the Immediate Release Formulation in Normal Volunteers
Rheumatoid ArthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

Various standard descriptive pharmacokinetics endpoints including: Cmin, Cmax, Tmax, AUC.
1 month

Secondary Endpoints

Safety laboratory testing including: blood electrolytes and liver and kidney function-related chemistries, complete blood counts, urinalysis, and electrocardiogram
1 month
Other safety parameters including: physical examination and vital signs.
1 month
Adverse Event Reporting as reported by subject and through investigator query and categorized by MedRA terminology.
1 month
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
50 mg oral suspensionEXPERIMENTALonce daily for one day
50 mg CR Type 1EXPERIMENTALonce daily for one day
50 mg CR Type 2EXPERIMENTALonce daily for one day
50 mg SR Type 3EXPERIMENTALonce daily for one day

Interventions

NameTypeDescription
suspension IRDRUG50 mg IR suspension once daily for one day
CR 1DRUG50 mg shorter release CR once daily for one day
CR 2DRUG50 mg medium release CR once daily for one day
CR 3DRUGlonger release SR formulation once daily for one day
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG ...

Countries:United States
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Frequently asked questions about IR

What is IR used for?

IR is an investigational small molecule being developed for rheumatoid arthritis. It is currently in Phase 1 clinical development and has not been approved by the FDA. The drug is being studied for its potential to treat this autoimmune condition.

Who makes IR?

IR is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The company is conducting clinical research on this investigational drug for rheumatoid arthritis.

What phase is IR in?

IR is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for the treatment of rheumatoid arthritis, with one completed Phase 1 trial.

What clinical trials is IR in?

IR has one completed Phase 1 clinical trial registered as NCT00782600. This study evaluated controlled release formulations of CE-224,535 against the immediate release formulation in normal volunteers. The trial enrolled 16 participants in the United States and was completed.

Is IR the same as CE-224,535?

IR is associated with the compound CE-224,535, as indicated in the clinical trial title. The study compared controlled release formulations of CE-224,535 against the immediate release formulation, suggesting IR may be a formulation or identifier for this compound.