Recent Updates
Recently added Catalysts

PF-06865571 Immediate release

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Apr 17, 2018

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

PF-06865571 Immediate release · 1 trial · 1 indication

Phase 1 1
NCT03372044A Study To Evaluate Different Formulations Of PF-06865571 In Healthy SubjectsHealthy
COMPLETED12 Analytics
PHASE1COMPLETED
A Study To Evaluate Different Formulations Of PF-06865571 In Healthy Subjects
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum Observed Plasma Concentration (Cmax) for PF-06865571
0,0.5,1,2,3,4,6,8,12,24,36,48 hours post dose in each period
Time to Reach Maximum Observed Concentration for PF-06865571
0,0.5,1,2,3,4,6,8,12,24,36,48 hours post dose in each period

Time to Reach Maximum Observed Plasma Concentration (Tmax)

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06865571
0,0.5,1,2,3,4,6,8,12,24,36,48 hours post dose in each period

Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

Area Under the Curve From Time Zero to Extrapolated Infinite Time for PF-06865571
0,0.5,1,2,3,4,6,8,12,24,36,48 hours post dose in each period

AUC (0-infinity)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-infinity). It is obtained from AUC (0-t) plus AUC (t-infinity).

Plasma Decay Half-Life (t1/2) for PF-06865571
0,0.5,1,2,3,4,6,8,12,24,36,48 hours post dose in each period

Plasma Decay Half-Life (t1/2)

Secondary Endpoints

Number of subjects with adverse events (AEs)
Baseline up to 35 days after last dose
Number of subjects with laboratory tests findings of potential clinical importance
Baseline (Day 0) up to 48 hours after last dose of study medication
Number of subjects with electrocardiogram (ECG) findings of potential clinical importance
Baseline (Day 0) up to 48 hours after last dose of study medication
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
PF-06865571EXPERIMENTALTreatment

Interventions

NameTypeDescription
PF-06865571 Immediate release suspensionDRUGSuspension
PF-06865571 Slow release MR tabletsDRUGModified release tablets
PF-06865571 Fast release MR tabletsDRUGModified release tablets
PF-06865571 Immediate release tabletsDRUGImmediate release tablets
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy males and female of non-childbearing potential * Age of 18-55, inclusive * Body Mass Index 17.5 to 30.5 kg/m2, inclusive * Body weight \>50 kg * Not on any prescription or non-prescription drugs within 7 days or 5 half-lives prior to first dose. Exclusion Criteria: *...

Countries:Belgium
Unlock Eligibility Criteria

Frequently asked questions about PF-06865571 Immediate release

What is PF-06865571 Immediate release used for?

PF-06865571 Immediate release is an investigational small molecule being studied in healthy subjects. It is currently in Phase 1 clinical development, with a completed trial evaluating different formulations of the drug in healthy volunteers.

Who makes PF-06865571 Immediate release?

PF-06865571 Immediate release is being developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE.

What phase is PF-06865571 Immediate release in?

PF-06865571 Immediate release is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials.

What clinical trials is PF-06865571 Immediate release in?

PF-06865571 Immediate release has one completed clinical trial, NCT03372044, titled "A Study To Evaluate Different Formulations Of PF-06865571 In Healthy Subjects." This Phase 1 trial enrolled 12 healthy participants in Belgium and was not blinded or controlled.

Is PF-06865571 Immediate release the same as PF-06865571?

PF-06865571 Immediate release is a specific formulation of the drug PF-06865571. The clinical trial NCT03372044 was designed to evaluate different formulations of PF-06865571, including the immediate release version, in healthy subjects.