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PF-06266047

Phase 1

Undisclosed | Small molecule | Other |Pfizer, Inc.|Trials Updated: Jun 24, 2016

PF-06266047 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Sep 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment25

FDA Designations

No designations recorded

PF-06266047 clinical trials

PF-06266047 · 1 trial · 1 indication

Phase 1 1
NCT02539550A Study To Evaluate the Safety, Tolerability, And Pharmacokinetics Of PF-06266047 In Healthy Adult SubjectsHealthy Volunteers
COMPLETED25 Analytics
PHASE1COMPLETED
A Study To Evaluate the Safety, Tolerability, And Pharmacokinetics Of PF-06266047 In Healthy Adult Subjects
Healthy VolunteersUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants with Adverse Events (AEs)
Baseline up to 1 day of dosing

Number of participants with AEs occurring after first dose of study drug. Relatedness to study drug will be assessed by investigator.

Number of subjects with standard safety laboratory test results of potential clinical significance
Baseline up to 1 day of dosing

Number of subjects with standard safety laboratory test results of potential clinical significance (according to pre-defined criteria).

Electrocardiogram (ECG)
0, 1, 2, 4, 8, 12, 24, 48, and 72 hours post-dose

Absolute values and changes from baseline for the ECG parameters

Orthostatic blood pressure and pulse rate
0, 1, 2, 4, 8, 12, 24, 48, and 72 hours post-dose

Absolute values and changes from baseline for blood pressure and pulse rate

Abnormal rhythms as observed on continuous cardiac telemetry
Baseline period of at least 2 hours and continuous tracing for at least 8 hours following single dose administration

All abnormal rhythms will be reviewed by the study physician for the presence of rhythms of potential clinical concern. The time, duration and description of any clinically significant event will be recorded.

Secondary Endpoints

Maximum Observed Plasma Concentration (Cmax)
0, 0.5, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
0, 0.5, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours post-dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
0, 0.5, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours post-dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATORPlacebo
PF-06266047EXPERIMENTALPF-06266047

Interventions

NameTypeDescription
PlaceboDRUGPlacebo
PF-06266047DRUGPF-06266047
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Healthy female subjects of non-childbearing potential and/or male subjects who, at the time of screening, are 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 exa...

Countries:Belgium
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Frequently asked questions about PF-06266047

What is PF-06266047?

PF-06266047 is an investigational small molecule developed by Pfizer, Inc. (NYSE: PFE). It has been studied in a Phase 1 clinical trial in healthy adult volunteers. The specific therapeutic indication for PF-06266047 has not been disclosed.

Who makes PF-06266047?

PF-06266047 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 PF-06266047 in healthy volunteers.

What phase is PF-06266047 in?

PF-06266047 is in Phase 1 clinical development. It has completed one Phase 1 trial, NCT02539550, which evaluated safety, tolerability, and pharmacokinetics in healthy adult subjects. No later-phase trials have been reported.

What clinical trials is PF-06266047 in?

PF-06266047 has been studied in one completed Phase 1 trial, NCT02539550, titled "A Study To Evaluate the Safety, Tolerability, And Pharmacokinetics Of PF-06266047 In Healthy Adult Subjects." The trial enrolled 25 healthy volunteers in Belgium and was randomized, double-blind, and placebo-controlled.

Is PF-06266047 FDA approved?

No, PF-06266047 is not FDA approved. It is an investigational drug that has completed a Phase 1 clinical trial in healthy volunteers. It remains in clinical development and has not been approved for any indication.