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PF-06667272

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Oct 19, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

Clinical trial landscape

PF-06667272 · 1 trial · 1 indication

Phase 1 1
NCT03126149First in Human Study for PF-06667272Healthy
COMPLETED16 Analytics
PHASE1COMPLETED
First in Human Study for PF-06667272
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Study Endpoints

Primary Endpoints

Number of Subjects With Treatment Emergent Treatment-Related Adverse Events (AEs) or other safety concerns
Baseline (Day 1, hour 0) up to 28 days after last dose of study medication

Assessment by adverse event monitoring, 12 lead ECGs, telemetry, vital signs and clinical safety laboratory measurements. Treatment-related AE was any untoward medical occurrence attributed to study drug in a subject who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to Drug was assessed by the investigator (Yes/No). Subjects with multiple occurrences of an AE within a category were counted once within the category.

Secondary Endpoints

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06667272 and PF-06818073
0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0- infinity)] for PF-06667272 and PF-06818073 (as permitted)
0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose
Maximum Observed Plasma Concentration (Cmax) for PF-06667272 and PF-06818073
0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Cohort 1_Period 1_ActiveEXPERIMENTALSingle ascending dose of PF-06667272
Cohort 1_Period 1_PlaceboPLACEBO_COMPARATORSingle dose of placebo
Cohort 1_Period 2_ActiveEXPERIMENTALSingle ascending dose of PF-06667272
Cohort 1_Period 2_PlaceboPLACEBO_COMPARATORSingle dose of placebo
Cohort 1_Period 3_ActiveEXPERIMENTALSingle ascending dose of PF-06667272
Cohort 1_Period 3_PlaceboPLACEBO_COMPARATORSingle dose of placebo
Cohrot 1_Period 4_ActiveEXPERIMENTALSingle ascending dose of PF-06667272
Cohort 1_Period 4_PlaceboPLACEBO_COMPARATORSingle dose of placebo
Cohort 2_Period 1_ActiveEXPERIMENTALSingle ascending dose of PF-06667272
Cohort 2_Period 1_PlaceboPLACEBO_COMPARATORSingle dose of placebo
Cohort 2_Period 2_ActiveEXPERIMENTALSingle ascending dose of PF-06667272
Cohort 2_Period 2_PlaceboPLACEBO_COMPARATORSingle dose of placebo
Cohort 2_Period 3_ActiveEXPERIMENTALSingle ascending dose of PF-06667272
Cohort 2_Period 3_PlaceboPLACEBO_COMPARATORSingle dose of placebo
Cohort 2_Period 4_ActiveEXPERIMENTALSingle ascending dose of PF-06667272
Cohort 2_Period 4_PlaceboPLACEBO_COMPARATORSingle dose of placebo

Interventions

NameTypeDescription
PF-06667272DRUGSingle ascending dose of PF-06667272
PlaceboOTHERSingle dose of placebo
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy males and female of non-childbearing potential; * Body Mass Index 17.5-30.5 kg/m2; * Body weight \>50 kg; Exclusion Criteria: * Evidence of history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychi...

Countries:Belgium
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Frequently asked questions about PF-06667272

What is PF-06667272?

PF-06667272 is an investigational small molecule being developed by Pfizer, Inc. (PFE). It is currently in Phase 1 clinical development. The drug has been studied in healthy volunteers, and its therapeutic area is classified as Other.

What is PF-06667272 used for?

PF-06667272 is being studied for use in healthy volunteers. It is an investigational small molecule in Phase 1 clinical development. The drug has not been approved for any medical condition and is still in the early stages of clinical testing.

Who makes PF-06667272?

PF-06667272 is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker symbol PFE. The company is conducting clinical trials to evaluate this investigational small molecule in healthy volunteers.

What phase is PF-06667272 in?

PF-06667272 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied in healthy volunteers as part of early-stage clinical trials.

What clinical trials is PF-06667272 in?

PF-06667272 has one completed Phase 1 clinical trial, identified as NCT03126149, titled "First in Human Study for PF-06667272." This trial enrolled 16 healthy volunteers in Belgium and was a randomized, double-blind, placebo-controlled study.

Is PF-06667272 FDA approved?

PF-06667272 is not FDA approved. It is an investigational small molecule currently in Phase 1 clinical development. The drug has been studied in healthy volunteers, but it has not completed the clinical trials necessary for regulatory approval.