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PF-3864086

Phase 1

Pain | Small molecule | Pain |Pfizer, Inc.|Last Updated: Jan 8, 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment28

FDA Designations

No designations recorded

Clinical trial landscape

PF-3864086 · 1 trial · 1 indication

Phase 1 1
NCT00747058A Study To Investigate The Safety, Toleration And Pharmacokinetics Of Single Oral Doses Of PF-03864086 In Healthy Male SubjectsPain
COMPLETED28 Analytics
PHASE1COMPLETED
A Study To Investigate The Safety, Toleration And Pharmacokinetics Of Single Oral Doses Of PF-03864086 In Healthy Male Subjects
PainUnlock trial analytics

Study Endpoints

Primary Endpoints

Pharmacokinetics
measured intensively in the first 48 hours and continue out to day 14
Tolerability
measured intensively in the first 48 hours and continue out to day 14

Secondary Endpoints

Temperature change
continuous recording over the first 48h post dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
healthy volunteersEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
PF-3864086DRUGThe dosage form is POS (powdered oral suspension). Each subject will have 5 periods and the frequency (and duration) is once per period. The doses have been left flexible within the protocol but are listed as: 3, 10, 30, 60, 120, 240, 480 and 720 mg with an option to insert an additional dose cohort as well.
PlaceboDRUGPlacebo
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Eligibility Criteria

Age Range21 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * healthy male volunteers * no drug history * no other medication for 28 pre-dose Exclusion Criteria: * age below 21 years * age above 55 years

Countries:Belgium
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Frequently asked questions about PF-3864086

What is PF-3864086 used for?

PF-3864086 is an investigational small molecule being developed for the treatment of pain. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied for its safety, tolerability, and pharmacokinetic profile in healthy subjects.

Who makes PF-3864086?

PF-3864086 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is an investigational small molecule in Phase 1 clinical development for the treatment of pain.

What phase is PF-3864086 in?

PF-3864086 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for the treatment of pain, with one completed Phase 1 clinical trial evaluating its safety, tolerability, and pharmacokinetics.

What clinical trials is PF-3864086 in?

PF-3864086 has one completed clinical trial, identified as NCT00747058. This Phase 1 study investigated the safety, toleration, and pharmacokinetics of single oral doses of PF-03864086 in healthy male subjects. The trial enrolled 28 participants and was conducted in Belgium.

Is PF-3864086 the same as PF-03864086?

Yes, PF-3864086 is the same drug as PF-03864086. The clinical trial NCT00747058 refers to the drug as PF-03864086, while the drug is also known as PF-3864086. Both names refer to the same investigational small molecule being developed for pain.