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PF-06743649

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Jan 19, 2015

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

Clinical trial landscape

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 used for?

PF-06743649 is an investigational small molecule being studied in healthy volunteers. It is being evaluated for safety, toleration, pharmacokinetics, and pharmacodynamics after multiple oral doses. The drug is in Phase 1 clinical development and is not approved for any indication.

Who makes PF-06743649?

PF-06743649 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. The company is conducting clinical research on this investigational small molecule in healthy participants.

What phase is PF-06743649 in?

PF-06743649 is in Phase 1 clinical development. A Phase 1 study has been completed, and the drug remains investigational. It has not been approved by regulatory authorities for any use.

What clinical trials is PF-06743649 in?

PF-06743649 has one completed clinical trial, NCT02151617, which evaluated multiple oral doses in healthy people. The study assessed safety, toleration, pharmacokinetics, and pharmacodynamics. It enrolled 40 participants in the United States and was a randomized, double-blind, controlled trial.

Is PF-06743649 FDA approved?

PF-06743649 is not FDA approved. It is an investigational drug that has completed a Phase 1 study in healthy volunteers. The drug is still in clinical development and has not been authorized for marketing or patient use.