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PF-06273340

Phase 1

PAIN | Small molecule | Pain |Pfizer, Inc.|Trials Updated: Jul 4, 2012

PF-06273340 development status

Highest phase Phase 1
Registered trials 3 across 1 sponsor since Oct 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

PF-06273340 clinical trials

PF-06273340 · 1 trial · 1 indication

Phase 1 1
NCT01601834A First In Human Study In Healthy People To Evaluate Safety, Toleration And Time Course Of Plasma Concentration Of Single Oral Doses Of PF-06273340PAIN
COMPLETED20 Analytics
PHASE1COMPLETED
A First In Human Study In Healthy People To Evaluate Safety, Toleration And Time Course Of Plasma Concentration Of Single Oral Doses Of PF-06273340
PAINUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum observed plasma concentration (Cmax)
0,0.25,0.5,1,1.5,2,4,6,8,12,24,36,48,72 hours post-dose
Time of maximum concentration (Tmax)
0,0.25,0.5,1,1.5,2,4,6,8,12,24,36,48,72 hours post-dose
Area under the plasma concentration time profile from time zero to the time of last quantifiable concentration (AUClast)
0,0.25,0.5,1,1.5,2,4,6,8,12,24,36,48,72 hours post-dose
Area under the plasma concentration time profile from time zero extrapolated to inifinite time (AUCinf)
0,0.25,0.5,1,1.5,2,4,6,8,12,24,36,48,72 hours post-dose
Area under the plasma concentration time profile from time zero to quantifiable concentration 24 h post dose (AUC24)
0,0.25,0.5,1,1.5,2,4,6,8,12,24,36,48,72 hours post-dose
Apparent Clearance (CL/F)
0,0.25,0.5,1,1.5,2,4,6,8,12,24,36,48,72 hours post-dose
Apparent Volume of Distribution (Vz/F)
0,0.25,0.5,1,1.5,2,4,6,8,12,24,36,48,72 hours post-dose
t1/2 = Terminal Elimination half life
0,0.25,0.5,1,1.5,2,4,6,8,12,24,36,48,72 hours post-dose
Urine: Ae24 (amount excreted in urine), Ae24% (%dose excreted in urine to time 24 h) and CLr (Renal Clearance) for selected doses
up to 24 h
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Cohort 1: Experimental intervention: PF-06273340 or placeboEXPERIMENTALSubjects in Cohort 1 will receive single ascending doses of PF-06273340 or placebo to investigate the safety/tolerability and PK of PF-06273340. The effect of food on PK may also be investigated.
Cohort 2: Experimental intervention: PF-06273340 or placeboEXPERIMENTALSubjects in Cohort 2 will receive single ascending doses of PF-06273340 or placebo to investigate the safety/tolerability and PK of PF-06273340. The effect of food on PK may also be investigated.

Interventions

NameTypeDescription
PF-06273340 or PlaceboDRUGPF-06273340 will be administered as an extemporaneously prepared solution for all doses. Correspondingly, placebo doses will be administered as solution.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male subjects or female subjects of non-child bearing potential between the ages of 18 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 * Su...

Countries:Belgium
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Frequently asked questions about PF-06273340

What is PF-06273340?

PF-06273340 is an investigational small molecule drug being developed by Pfizer, Inc. for the treatment of pain. It has been studied in a Phase 1 first-in-human clinical trial in healthy volunteers. It is not an approved medicine and remains in early clinical development.

Who makes PF-06273340?

PF-06273340 is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored the Phase 1 first-in-human study of the compound in healthy volunteers.

What phase is PF-06273340 in?

PF-06273340 is in Phase 1 clinical development. Its only recorded trial, NCT01601834, was a Phase 1 first-in-human study that has been completed. The drug is investigational and has not been approved for any indication.

What clinical trials is PF-06273340 in?

PF-06273340 has been evaluated in one clinical trial, NCT01601834, titled A First In Human Study In Healthy People To Evaluate Safety, Toleration And Time Course Of Plasma Concentration Of Single Oral Doses Of PF-06273340. The Phase 1 study enrolled 20 healthy adult volunteers in Belgium and is completed.

What is PF-06273340 used for?

PF-06273340 is being studied for the treatment of pain. Its single completed Phase 1 trial listed pain as the condition under study, and it was tested in healthy volunteers rather than patients. No approved use exists for this investigational compound.

How was the PF-06273340 Phase 1 trial designed?

The Phase 1 trial NCT01601834 was a randomized, double-blind, controlled first-in-human study of single oral doses of PF-06273340. It enrolled 20 healthy volunteers of all sexes, aged 18 years and older, in Belgium, and assessed safety, toleration, and the time course of plasma concentration.