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PF-06266047

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment25
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02539550A Study To Evaluate the Safety, Tolerability, And Pharmacokinetics Of PF-06266047 In Healthy Adult SubjectsPHASE1 COMPLETED 25Aug 1, 2015May 1, 2016Jun 24, 20161 Belgium
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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 — 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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