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PF-04457845, FAAH inhibitor

Phase 1

Acute Pain | Small molecule | Pain |Pfizer, Inc.|Last Updated: Aug 6, 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment41

FDA Designations

No designations recorded

Clinical trial landscape

PF-04457845, FAAH inhibitor · 1 trial · 2 indications

Phase 1 1
NCT00836082A Multiple Dose Trial Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04457845 in Healthy VolunteersAcute Pain
COMPLETED41 Analytics
PHASE1COMPLETED
A Multiple Dose Trial Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04457845 in Healthy Volunteers
Acute PainUnlock trial analytics

Study Endpoints

Primary Endpoints

To characterize the multiple-dose pharmacokinetics of PF-04457845.
14 Days
To characterize the relationship between PF-04457845 and the level of anandamide and level of FAAH enzyme inhibition in healthy adult volunteers following multiple dosing.
14 Days
To evaluate the safety and tolerability of multiple oral doses of PF-04457845.
14 Days
To determine the effect on food on PF-04457845 pharmacokinetics following administration of single doses of 4mg and 8mg.
7-14 Days
To determine the effect on food on PF-04457845 safety following administration of single doses of 4mg and 8mg.
7-14 Days

Secondary Endpoints

CogState/GMLT
14 Days
Telemetry
14 Days
Neurologic Exam
14 Days
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL

Treatment Arms

ArmTypeDescription
Cohort 1 (N=10)EXPERIMENTALPlacebo-controlled, escalating multiple doses of 0.5mg per day for 14 days.
Cohort 2 (N=10)EXPERIMENTALPlacebo-controlled, escalating multiple doses of 1mg per day for 14 days.
Cohort 3 (N=10)EXPERIMENTALPlacebo-controlled, escalating multiple doses of 4mg per day for 14 days.
Cohort 4 (N=10)EXPERIMENTALPlacebo-controlled, escalating multiple doses of 8mg per day for 14 days.

Interventions

NameTypeDescription
PF-04457845, FAAH inhibitorDRUGOral solution of 0.5mg given once daily for 14 days.
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Eligibility Criteria

Age Range21 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and/or female subjects (of non childbearing potential) 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 puls...

Countries:Singapore
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Competitive Landscape -Acute Kidney Injury 14 trials (matched to "Acute Pain")

Frequently asked questions about PF-04457845, FAAH inhibitor

What is PF-04457845 used for?

PF-04457845 is an investigational small molecule being studied for acute pain, chronic pain, and osteoarthritis of the knee. It has been evaluated in healthy volunteers and in patients with knee osteoarthritis. The drug is not approved and remains in clinical development.

Who makes PF-04457845?

PF-04457845 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. The company has sponsored clinical trials of the drug in healthy volunteers and in patients with osteoarthritis of the knee.

What phase is PF-04457845 in?

PF-04457845 has completed Phase 1 and Phase 2 clinical trials. The most advanced study was a Phase 2 trial in patients with osteoarthritis of the knee. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is PF-04457845 in?

PF-04457845 has been studied in three completed trials: NCT00836082, a Phase 1 multiple dose trial in healthy volunteers; NCT00918164, a Phase 1 bioavailability and food effect study; and NCT00981357, a Phase 2 trial in patients with osteoarthritis of the knee.

Is PF-04457845 the same as other drugs?

PF-04457845 is the primary name used in clinical trial records for this investigational drug. No alternative names have been reported in the available clinical trial information.