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FXR 450

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Mar 13, 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment64

FDA Designations

No designations recorded

Clinical trial landscape

FXR 450 · 1 trial · 1 indication

Phase 1 1
NCT00499629Study Evaluating the Safety of FXR-450 in Healthy SubjectsHealthy
COMPLETED64 Analytics
PHASE1COMPLETED
Study Evaluating the Safety of FXR-450 in Healthy Subjects
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Study Endpoints

Primary Endpoints

Safety, tolerability
4 days

Secondary Endpoints

pharmacokinetics
4 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL

Treatment Arms

ArmTypeDescription
1ACTIVE_COMPARATORArm 1: FXR 450
2PLACEBO_COMPARATORPlacebo

Interventions

NameTypeDescription
FXR 450DRUGcapsule, single oral doses from 10 mg to 450 mg
placeboDRUGcapsule similar to active drug
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Men or women of nonchildbearing potential (WONCBP) aged 18 to 50 years inclusive at screening. * Healthy as determined by the investigator on the basis of screening evaluations. * Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to...

Countries:United States
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Frequently asked questions about FXR 450

What is FXR 450?

FXR 450 is an investigational small molecule being developed by Pfizer, Inc. It is currently in Phase 1 clinical development. The drug has been studied in healthy volunteers to evaluate its safety, as part of a completed clinical trial.

What is FXR 450 used for?

FXR 450 is being studied for use in healthy subjects. The completed Phase 1 trial focused on evaluating the safety of FXR-450 in healthy volunteers. Its potential therapeutic application has not been specified beyond this initial safety assessment.

Who makes FXR 450?

FXR 450 is being developed by Pfizer, Inc., which is publicly traded under the ticker symbol PFE. The company conducted a Phase 1 clinical trial to evaluate the safety of the drug in healthy subjects.

What phase is FXR 450 in?

FXR 450 is in Phase 1 clinical development. The drug is investigational and has not been approved by regulatory authorities. A Phase 1 trial assessing its safety in healthy subjects has been completed.

What clinical trials is FXR 450 in?

FXR 450 has one completed clinical trial, identified as NCT00499629, titled "Study Evaluating the Safety of FXR-450 in Healthy Subjects." This Phase 1 trial enrolled 64 participants in the United States and was placebo-controlled, randomized, and double-blind.

Is FXR 450 the same as FXR-450?

Yes, FXR 450 is the same as FXR-450. The clinical trial NCT00499629 uses the name FXR-450, and both names refer to the same investigational drug being developed by Pfizer, Inc.