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PF-06260414

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Nov 14, 2018

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 Enrollment72
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02070939Study To Evaluate Safety And Tolerability Of Single And Multiple Ascending Doses Of PF- 06260414 In Healthy Western And Japanese Male SubjectsPHASE1 COMPLETED 72 — — Feb 1, 2014Mar 1, 2015Nov 14, 20181 United States
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Study Endpoints
Primary Endpoints
Changes from baseline vital signs (blood pressure, pulse rate, oral temperature and respiration rate)
6 weeks
Changes from baseline in 12-lead ECG parameters
6 weeks

Quantitative changes in ECG intervals

Incidence and severity of treatment emergent adverse events and withdrawals due to treatment emergent adverse events
6 weeks
Incidence and magnitude of treatment emergent clinical laboratory abnormalities including hematology (including total Hb and hematocrit), chemistry, fasting glucose, urinalysis
6 weeks
24 hour creatinine clearance (baseline and day 14).
Baseline, Day 14
Changes from baseline in total testosterone, free testosterone, estradiol, LH, FSH, SHBG.
6 weeks
Changes from baseline in Prostate Specific Antigen (PSA).
6 weeks
Changes from baseline in total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides.
6 weeks
Secondary Endpoints
Single Dose: Cmax, Tmax, AUClast, AUCinf, CL/F, Vz/F, and t½,Cmax(dn), AUCinf(dn), AUClast(dn), t½.
6 weeks
Multiple Dose: Cmax, Tmax Ctrough, C,av,AUC,CL/F, Vz/F, Rac , Rac,Cmax , PTR, Cmax(dn),AUCτ(dn), t½.
6 weeks
Urinary Pharmacokinetics: Amount of PF 06260414 excreted unchanged (AE and AE%), renal clearance (CLr).
6 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
SAD cohorts 1-7 Experimental ArmEXPERIMENTAL -
SAD Cohorts 1-7 Placebo ArmPLACEBO_COMPARATOR -
MAD cohorts 2-6 Experimental ArmEXPERIMENTAL -
MAD cohorts 2-6 Placebo ArmPLACEBO_COMPARATOR -
Japanese MAD cohort 7 Experimental armEXPERIMENTAL -
Japanese MAD cohort 7 Placebo ArmPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
PF-06260414DRUGSubjects will receive single doses of 1,3,6,30,100,200, 400 mg of PF-06260414 (solution) in a dose escalating format
PlaceboDRUGSubjects will receive single doses of PF-06260414 matching placebo (solution) in a dose escalation format
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Eligibility Criteria
Age Range21 Years — 50 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male between the ages of 21 and 50 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory...

Countries:United States
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