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Formulation 1

Phase 1

Rheumatoid Arthritis | Small molecule | Other |Pfizer, Inc.|Trials Updated: Jul 6, 2011

Formulation 1 development status

Highest phase Phase 1
Registered trials 8 across 4 sponsors since May 2011

Formulation 1 target and mechanism

ModalitySmall molecule

Also known as CR 1

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Formulation 1 clinical trials

Formulation 1 · 1 trial · 1 indication

Phase 1 1
NCT01351129Single Dose Study To Compare Pharmacokinietics Of 3 Different Formulations Of PF-04991532 In Healthy VolunteersHealthy
COMPLETED12 Analytics
PHASE1COMPLETED
Single Dose Study To Compare Pharmacokinietics Of 3 Different Formulations Of PF-04991532 In Healthy Volunteers
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Area under the plasma concentration versus time profile (AUC)
predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12,24,36,48 hrs postdose

Secondary Endpoints

Max observed plasma concentration (Cmax)
predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12,24,36,48 hrs postdose
Time of Cmax (Tmax)
predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12,24,36,48 hrs postdose
Concentration at 24 hours postdose (C24hr)
24 hrs postdose
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Formulation 1EXPERIMENTAL -
Formulation 2EXPERIMENTAL -
Formulation 3EXPERIMENTAL -

Interventions

NameTypeDescription
Formulation 1DRUG150-mg immediate release tablet (single dose)
Formulation 2DRUG150-mg modified release capsule, short duration (single dose)
Formulation 3DRUG150-mg modified release capsule, long duration (single dose)
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Eligibility Criteria

Age Range21 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and/or female (non-childbearing potential) subjects between the ages of 21 and 55 years, inclusive. * Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs). * An informed consent document signed and dated by the subject. Exclusion...

Countries:Singapore
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Frequently asked questions about Formulation 1

What is Formulation 1?

Formulation 1 is an investigational small molecule developed by Pfizer, Inc. (ticker: PFE). It is being studied for rheumatoid arthritis and has completed a Phase 1 clinical trial. It is also known by the alternative names CR 1 and 1.

What is Formulation 1 used for?

Formulation 1 is being developed for the treatment of rheumatoid arthritis. It is an investigational therapy and has not been approved for any indication. Its only completed clinical trial to date enrolled healthy volunteers, not patients with rheumatoid arthritis.

Who makes Formulation 1?

Formulation 1 is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker symbol PFE. Pfizer is the sponsor of the clinical program for this investigational small molecule.

What phase is Formulation 1 in?

Formulation 1 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The completed study enrolled 12 healthy volunteers in Singapore.

What clinical trials is Formulation 1 in?

Formulation 1 has been evaluated in one completed Phase 1 trial, NCT01351129, titled "Single Dose Study To Compare Pharmacokinietics Of 3 Different Formulations Of PF-04991532 In Healthy Volunteers." The trial enrolled 12 healthy volunteers in Singapore and was controlled and randomized but not double-blind.

Is Formulation 1 the same as CR 1?

Yes, Formulation 1 is also known as CR 1 and 1. These alternative names refer to the same investigational small molecule developed by Pfizer, Inc. for rheumatoid arthritis.