Recent Updates
Recently added Catalysts

PF-06266047

Phase 1

Healthy Volunteers | Small molecule | Other |Pfizer, Inc.|Last Updated: Jun 24, 2016

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment25

FDA Designations

No designations recorded

Clinical trial landscape

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
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATORPlacebo
PF-06266047EXPERIMENTALPF-06266047

Interventions

NameTypeDescription
PlaceboDRUGPlacebo
PF-06266047DRUGPF-06266047
Unlock Study Design Details

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
Unlock Eligibility Criteria

Frequently asked questions about PF-06266047

What is PF-06266047 used for?

PF-06266047 is an investigational small molecule being studied in healthy volunteers. It is not approved for any disease and is in clinical development to evaluate its safety, tolerability, and pharmacokinetics. The drug is being developed by Pfizer, Inc. (PFE).

Who makes PF-06266047?

PF-06266047 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker PFE. The drug is an investigational small molecule currently in Phase 1 clinical development for use in healthy volunteers.

What phase is PF-06266047 in?

PF-06266047 is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. A Phase 1 study has been completed to assess its safety, tolerability, and pharmacokinetics in healthy adult subjects.

What clinical trials is PF-06266047 in?

PF-06266047 has one completed clinical trial, identified as NCT02539550. This Phase 1 study evaluated the safety, tolerability, and pharmacokinetics of PF-06266047 in healthy adult subjects. The trial was conducted in Belgium with 25 participants and was placebo-controlled and double-blind.

Is PF-06266047 FDA approved?

PF-06266047 is not FDA approved. It is an investigational drug in Phase 1 clinical development. The completed trial, NCT02539550, was a Phase 1 study in healthy volunteers, and the drug has not been approved for any medical use.