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PF-06678552

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Jul 31, 2014

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-BlindCONTROLLED
Total Trials1
Total Enrollment38
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02079922A Multiple Dose Study Of PF-06678552 In Healthy SubjectsPHASE1 COMPLETED 38 — — Mar 1, 2014Jul 1, 2014Jul 31, 20141 Belgium
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Study Endpoints
Primary Endpoints
Assessment of adverse events (AEs), clinical laboratory tests, vital signs (including blood pressure and pulse rate), and cardiac conduction intervals as assessed by 12 lead ECG.
0 to 24 days post dose
Secondary Endpoints
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06644927 on day 1
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06644927 on day 7
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06644927 on day 14
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Cohort 1EXPERIMENTALSingle dose level of PF-06678552 or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
Cohort 2EXPERIMENTALSingle dose level of PF-06678552 or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
Cohort 3EXPERIMENTALSingle dose level of PF-06678552 or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
Cohort 4EXPERIMENTALSingle dose level of PF-06678552 or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
Cohort 5EXPERIMENTALSingle dose level of PF-06678552 or placebo will be provided either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
Cohort 6EXPERIMENTALSingle dose level of PF-06678552 or placebo will be provided either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
Interventions
NameTypeDescription
PF-06678552DRUGPF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
PlaceboDRUGPF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and/or female subjects of non-childbearing potential. * Body Mass Index (BMI) of 18 to 30.5 kg/m2; and a total body weight \>50 kg * Low density lipoprotein cholesterol between 115 mg/dL and 190 mg/dL Exclusion Criteria: * Evidence or history of clinically signi...

Countries:Belgium
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