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PF-04995274

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Dec 3, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials4
Total Enrollment114

FDA Designations

No designations recorded

Clinical trial landscape

PF-04995274 · 4 trials · 1 indication

Phase 1 4
NCT01193062Study In Healthy Subjects To Evaluate The Changes In The Protein sAPP-Alpha In Cerebrospinal Fluid Following A Single Oral Dose Of PF-04995274Healthy
COMPLETED18 Analytics
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.Healthy
COMPLETED60 Analytics
NCT01173757To Evaluate The Relationship Between Plasma Drug Levels And Receptor Binding In Brain Using PET (Positron Emission Tomography) In Healthy VolunteersHealthy
COMPLETED8 Analytics
NCT01091272A Study To Evaluate The Safety, Tolerability And Plasma Drug Levels Following A Single Dose Of PF-04995274 In Healthy Adult VolunteersHealthy
COMPLETED28 Analytics
PHASE1COMPLETED
Study In Healthy Subjects To Evaluate The Changes In The Protein sAPP-Alpha In Cerebrospinal Fluid Following A Single Oral Dose Of PF-04995274
HealthyUnlock trial analytics
PHASE1COMPLETED
A 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.
HealthyUnlock trial analytics
PHASE1COMPLETED
To Evaluate The Relationship Between Plasma Drug Levels And Receptor Binding In Brain Using PET (Positron Emission Tomography) In Healthy Volunteers
HealthyUnlock trial analytics
PHASE1COMPLETED
A Study To Evaluate The Safety, Tolerability And Plasma Drug Levels Following A Single Dose Of PF-04995274 In Healthy Adult Volunteers
HealthyUnlock trial analytics

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 to 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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Frequently asked questions about PF-04995274

What is PF-04995274?

PF-04995274 is an investigational small molecule being developed by Pfizer, Inc. (PFE). It has been studied in healthy volunteers in Phase 1 clinical trials to evaluate its safety, tolerability, and blood levels. The drug is not approved and remains in clinical development.

What is PF-04995274 used for?

PF-04995274 is being studied for use in healthy volunteers, primarily to assess its safety, tolerability, and pharmacokinetics. It has not been studied in any patient population or disease indication. All completed trials enrolled healthy adults and elderly volunteers.

Who makes PF-04995274?

PF-04995274 is developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker PFE. Pfizer has sponsored all four clinical trials of this investigational small molecule.

What phase is PF-04995274 in?

PF-04995274 is in Phase 1 clinical development. All four trials of the drug have been completed, with a total enrollment of 114 healthy volunteers. The drug is investigational and has not received regulatory approval.

What clinical trials is PF-04995274 in?

PF-04995274 has been studied in four completed Phase 1 trials: NCT01091272 (single dose in healthy adults), NCT01169714 (multiple doses in healthy adult and elderly volunteers), NCT01173757 (PET study of receptor binding in brain), and NCT01193062 (cerebrospinal fluid sAPP-alpha changes). All trials enrolled healthy volunteers.

Is PF-04995274 the same as any other drug?

PF-04995274 is the only name provided for this investigational drug. No alternative names have been reported in the clinical trial records. It is a distinct small molecule being developed by Pfizer.