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PF-06743649

Phase 1

Undisclosed | Small molecule | Other |Pfizer, Inc.|Trials Updated: Jan 19, 2015

PF-06743649 development status

Highest phase Phase 1
Registered trials 3 across 1 sponsor since May 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

PF-06743649 clinical trials

PF-06743649 · 1 trial · 1 indication

Phase 1 1
NCT02151617A Study In Healthy People To Evaluate Safety, Toleration, Pharmacokinetics And Pharmacodynamics Of Multiple Oral Doses Of PF-06743649Healthy
COMPLETED40 Analytics
PHASE1COMPLETED
A Study In Healthy People To Evaluate Safety, Toleration, Pharmacokinetics And Pharmacodynamics Of Multiple Oral Doses Of PF-06743649
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum Observed Plasma Concentration (Cmax)
up to 14 days
Area Under the Curve from Time Zero to end of dosing interval (AUCtau)
up to 14 days
Time to Reach Maximum Observed Plasma Concentration (Tmax)
up to 14 days
Plasma Decay Half-Life (t1/2)
up to 14 days
Amount of drug recovered unchanged in urine during the dosing interval (Aetau)
up to 14 days
Percent of dose recovered unchanged in urine during the dosing interval(Aetau%)
up to 14 days
Renal clearance (CLr)
up to 14 days

Secondary Endpoints

Change from baseline in serum uric acid level
up to 14 days
Change from baseline in serum levels of xanthine and hypoxanthine
up to 14 days
Urinary uric acid levels
up to 14 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Cohort 1-PF-06743649 or placeboEXPERIMENTALSubjects will be randomized to receive PF-06743649 or placebo as 2 single doses in periods 1 and 2 either in the fed or fasted state followed by once daily dosing for 14 days in period 3
Cohort 2-PF-06743649 or placeboEXPERIMENTAL -
Cohort 3-PF-06743649 or placeboEXPERIMENTAL -
Cohort 4-PF-06743649 or placeboEXPERIMENTAL -
Cohort 5-PF-06743649 or placeboEXPERIMENTAL -

Interventions

NameTypeDescription
PF-06743649DRUG40 mg tablet one time once with a meal and once without a meal, followed by once daily dosing for 14 days
PlaceboDRUGPlacebo tablet one time once with a meal and once without a meal, followed by once daily dosing for 14 days
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and/or female subjects 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 pulse rate measurement, 12-lead ECG...

Countries:United States
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Frequently asked questions about PF-06743649

What is PF-06743649?

PF-06743649 is an investigational small molecule drug developed by Pfizer, Inc. It has been studied in a Phase 1 clinical trial in healthy adult volunteers, evaluating safety, toleration, pharmacokinetics, and pharmacodynamics after multiple oral doses. It is not approved for any indication and remains in early clinical development.

Who is developing PF-06743649?

PF-06743649 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored the Phase 1 study of the compound conducted in the United States.

What phase is PF-06743649 in?

PF-06743649 is in Phase 1 clinical development. Its only recorded trial, NCT02151617, was a Phase 1 study that has been completed. The drug is investigational and has not been approved by the FDA for any indication.

What clinical trials is PF-06743649 in?

PF-06743649 has been studied in one clinical trial, NCT02151617, titled a study in healthy people to evaluate safety, toleration, pharmacokinetics and pharmacodynamics of multiple oral doses of PF-06743649. The Phase 1 trial enrolled 40 healthy volunteers in the United States and is now completed, with no active trials ongoing.

How was the PF-06743649 Phase 1 trial designed?

The Phase 1 trial of PF-06743649, NCT02151617, was a randomized, double-blind, controlled study conducted in the United States. It enrolled 40 healthy adult volunteers of all sexes, aged 18 years and older, and assessed safety, toleration, pharmacokinetics, and pharmacodynamics following multiple oral doses of the drug.