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PF-04995274

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Dec 3, 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-BlindCONTROLLEDBiomarker
Total Trials4
Total Enrollment114
FDA Designations
No designations recorded
Clinical Trials (4)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01193062Study In Healthy Subjects To Evaluate The Changes In The Protein sAPP-Alpha In Cerebrospinal Fluid Following A Single Oral Dose Of PF-04995274PHASE1 COMPLETED 18 — — Sep 1, 2010Jan 1, 2011Dec 3, 20181 United States
NCT01169714A Study To Observe Safety And Blood Concentrations Of PF-04995274 During And Following the Administration of Multiple Doses Of PF-04995274 In Healthy Adult And Healthy Elderly Volunteers.PHASE1 COMPLETED 60 — — Aug 1, 2010Dec 1, 2010Jan 20, 20112 United States
NCT01173757To Evaluate The Relationship Between Plasma Drug Levels And Receptor Binding In Brain Using PET (Positron Emission Tomography) In Healthy VolunteersPHASE1 COMPLETED 8 — — Aug 1, 2010Nov 1, 2010Jun 1, 20113 United States
NCT01091272A Study To Evaluate The Safety, Tolerability And Plasma Drug Levels Following A Single Dose Of PF-04995274 In Healthy Adult VolunteersPHASE1 COMPLETED 28 — — Apr 1, 2010Sep 1, 2010Sep 20, 20101 Belgium
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Study Endpoints
Primary Endpoints
Safety Endpoints (AE's, Vital signs, ECG, Clinical safety laboratory endpoints, Clinical examinations)
duration of study
Cmax, Tmax, AUClast, AUCinf, and t1/2 of PF 04995274 and PF-05082547 in plasma, as the data permit
upto 5 days post dose
Cmax, Tmax, AUClast, AUCinf, and t1/2 of PF 04995274 and PF-05082547 in cerebrospinal fluid, as the data permit
upto 8 hrs post dose
Cmax, Tmax, AUClast, AUCinf, and t1/2 of s-APP alpha and Abeta fragments in cerebrospinal fluid, as the data permit
8 hours post dose
Safety Endpoints (Adverse events, Change from baseline in vital signs, Change from baseline in triplicate ECGs, Clinical safety laboratory, Clinical examinations, Digit Symbol Substitution Test (DSST))
Day 0 to Day 28
Pharmacokinetic endpoints Plasma concentration of PF 04995274 over time (eg, AUC, Cmax, Tmax, t1/2), Plasma concentration of PF 05082547 over time (eg, AUC, Cmax, Tmax, t1/2).
Day 0 to Day 28
Pharmacodynamic endpoint Aldosterone concentration in healthy adult subjects.
Day 0 to Day 14
Exposure response of overall 5HT4 receptor occupancy of PF-04995274
up to 3 days
5HT4 receptor occupancy by PF-04995274 at regions of interest within the human brain
up to 3 days
Safety Endpoints (AE's, Vital signs (supine & standing BP, PR), Triplicate ECG, 8 hours of cardiac telemetry postdose, Clinical safety laboratory endpoints, Digit Symbol Substitution Test (DSST), Drug Effect Questionnaire (DEQ), Clinical
up to 21 days post dose
examinations)
up to 21 days post dose
Cmax, Tmax, AUClast, AUCinf, and t1/2 of PF 04995274, as the data permit.
up to 7 days post dose
Cmax, Tmax, AUClast, AUCinf, and t1/2 of PF 05082547, as the data permit.
up to 7 days post dosing
Secondary Endpoints
PK/PD model
8 hours post dose
No secondary outcomes
Adverse events
up to 3 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeOTHER
Treatment Arms
ArmTypeDescription
Cohort 1EXPERIMENTALSubjects will be randomized to receive single oral doses of 0.1 mg, 10 mg, 15mg/ 40 mg PF-04995274 or a placebo
Cohort 2EXPERIMENTALSubjects will be receive single oral doses of PF-04995274 not exceeding 15mg or a placebo
Dosing Healthy AdultEXPERIMENTALAscending Doses in Healthy Adult Volunteers
Dosing Healthy ElderlyEXPERIMENTALDosing in Healthy Elderly volunteers
PF-04995274EXPERIMENTAL -
Cohort 3EXPERIMENTALSingle dose 4 period cross-over, placebo insertion, with food effect
Optional Cohort 4EXPERIMENTALSingle dose 3 period cross-over with placebo substitution
Interventions
NameTypeDescription
PF-04995274DRUGSubjects will be randomized to receive single oral doses of 0.1 mg, 10 mg, 15mg/ 40 mg PF-04995274 or a placebo
0.1 mg PF-04995274DRUG0.1 mg PF-04995274, qd, for 14 days or placebo
1 mg PF-04995274DRUG1 mg PF-04995274, qd, for 14 days or placebo
10 mg PF-04995274DRUG10 mg PF-04995274, qd, for 14 days or placebo
15 mg PF-04995274DRUG15 mg PF-04995274, qd, for 14 days or placebo
1.0 mg PF-04995274DRUG1.0 mg PF-04995274, qd, for 14 days or placebo
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * For all cohorts, healthy male and/or female subjects of nonchildbearing potential 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 examination, including blood pr...

Countries:United StatesBelgium
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