Recent Updates
Recently added Catalysts

PF-04457845, FAAH inhibitor

Phase 2

Osteoarthritis, Knee | Small Molecules | Musculoskeletal |Pfizer, Inc.|Trials Updated: Sep 19, 2017

PF-04457845, FAAH inhibitor target and mechanism

ModalitySmall Molecules

Also known as PF-04457845

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials2
Total Enrollment117

FDA Designations

No designations recorded

PF-04457845, FAAH inhibitor clinical trials

PF-04457845, FAAH inhibitor · 2 trials · 3 indications

Phase 2 1Phase 1 1
NCT00981357A Study To Investigate Whether PF-04457845 Is Effective In Treating Pain, Is Safe And Tolerable In Patients With Osteoarthritis Of The KneeOsteoarthritis, Knee
COMPLETED76 Analytics
PHASE2COMPLETED
A Study To Investigate Whether PF-04457845 Is Effective In Treating Pain, Is Safe And Tolerable In Patients With Osteoarthritis Of The Knee
Osteoarthritis, KneeUnlock trial analytics

Study Endpoints

Primary Endpoints

To evaluate the efficacy of PF-04457845 (administered QD) versus placebo in relieving pain as measured by the WOMAC Pain sub-score in patients with osteoarthritis of the knee
8 weeks
To evaluate the safety and tolerability of PF-04457845 in patients with osteoarthritis.
10 weeks
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

Efficacy of PF-04457845 (administered QD) versus placebo as measured by the WOMAC Stiffness domain score (Likert scale for 2 items, overall score ranges from 0-8) in patients with osteoarthritis of the knee.
8 weeks
Efficacy of PF-04457845 (administered QD) versus placebo as measured by the WOMAC Physical Function domain score (Likert scale for 17 items, overall score ranges from 0-68) in patients with osteoarthritis of the knee.
8 weeks
Efficacy of PF-04457845 (administered QD) versus placebo as measured by the WOMAC Total Score in patients with osteoarthritis of the knee.
8 weeks
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PF-04457845 followed by placeboEXPERIMENTAL -
Placebo followed by PF-04457845EXPERIMENTAL -
Naproxen followed by placeboACTIVE_COMPARATOR -
Placebo followed by NaproxenACTIVE_COMPARATOR -
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-04457845DRUGPF-04457845 4 mg tablet once daily / matched placebo
NaproxenDRUGNaproxen 500 mg tablet twice daily / matched placebo
PF-04457845, FAAH inhibitorDRUGOral solution of 0.5mg given once daily for 14 days.
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Subjects must have a diagnosis of Osteoarthritis (OA) of the knee confirmed by X-ray * Subjects must be willing and able to stop all current pain therapy for the duration of study. (Limited and specific pain therapy will be available throughout the study) * Subjects can be mal...

Countries:United StatesCanadaSwedenSingapore
Unlock Eligibility Criteria

Competitive Landscape -Osteoarthritis 134 trials (matched to "Osteoarthritis, Knee")

Frequently asked questions about PF-04457845, FAAH inhibitor

What is PF-04457845?

PF-04457845 is an investigational small molecule developed by Pfizer, Inc. (NYSE: PFE) for the treatment of pain. It has been studied in acute pain and in osteoarthritis of the knee. It is not an approved medicine and remains in clinical development.

What is PF-04457845 used for in osteoarthritis of the knee?

PF-04457845 was studied as a treatment for pain in patients with osteoarthritis of the knee. A completed Phase 2 trial, NCT00981357, enrolled 76 patients with knee osteoarthritis across the United States, Canada, and Sweden to investigate whether the drug was effective, safe, and tolerable for treating pain.

Who makes PF-04457845?

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

What phase is PF-04457845 in?

PF-04457845 is investigational and has been tested in Phase 1 and Phase 2 clinical trials. It is not FDA approved. A Phase 1 multiple dose trial in healthy volunteers and a Phase 2 trial in knee osteoarthritis have both been completed, and no trials are currently active.

What clinical trials is PF-04457845 in?

Two completed trials are registered for PF-04457845. NCT00981357 was a Phase 2 study of pain in patients with osteoarthritis of the knee, enrolling 76 participants. NCT00836082 was a Phase 1 multiple dose trial of safety, tolerability, pharmacokinetics, and pharmacodynamics in 41 healthy volunteers in Singapore.