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PF-06882961 Immediate Release

Phase 1

Undisclosed | Small molecule | Other |Pfizer, Inc.|Trials Updated: Jul 30, 2018

PF-06882961 Immediate Release target and mechanism

ModalitySmall molecule

Also known as PF-06882961 Immediate Release Tablet

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

PF-06882961 Immediate Release clinical trials

PF-06882961 Immediate Release · 1 trial · 1 indication

Phase 1 1
NCT03492697A Single Dose Crossover Study In Healthy Subjects To Evaluate Different Formulations Of PF-06882961Healthy Subjects
COMPLETED12 Analytics
PHASE1COMPLETED
A Single Dose Crossover Study In Healthy Subjects To Evaluate Different Formulations Of PF-06882961
Healthy SubjectsUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum Observed Plasma Concentration (Cmax) for PF-06882961
0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period
Time to Maximum Observed Plasma Concentration (Tmax) for PF-06882961
0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period
Area under the curve from time zero to last quantifiable concentration for PF-06882961 (AUClast)
0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period
Area under the curve from time zero to extrapolated infinite time for PF-06882961 (AUCinf), as data permit
0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period

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

Observed Plasma Concentration for PF-06882961 at 24 hours post-dose (C24)
24 hours post dose in each period
Plasma Decay Half-Life (t1/2) for PF-06882961, as data permit
0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Apparent clearance (CL/F) for PF-06882961, as data permit
0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period

Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes). Calculated as Dose/AUCinf

Peak-to-trough (PTR) ratio for PF-06882961
0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period

Calculated as ratio of Cmax to C24

Secondary Endpoints

Number of subjects with treatment-emergent adverse events (AEs)
Baseline to at least 28 days after last dose
AUClast for PF-06882961 for CR tablet (long) and IR tablet in fed state
0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose
AUCinf for PF-06882961 for CR tablet (long) and IR tablet in fed state, as data permit
0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
PF-06882961EXPERIMENTAL -

Interventions

NameTypeDescription
PF-06882961 Immediate Release TabletDRUGImmediate Release Tablet
PF-06882961 Controlled Release Tablet (long)DRUGControlled Release tablet (long)
PF-06882961 Controlled Release Tablet (short)DRUGControlled Release tablet (short)
PF-06882961 Immediate Release SolutionDRUGPF-06882961 Immediate Release solution
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy female subjects of nonchildbearing potential and/or male subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive * Body mass index (BMI) within 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb) * Evidence of a personally si...

Countries:United States
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Frequently asked questions about PF-06882961 Immediate Release

What is PF-06882961 Immediate Release?

PF-06882961 Immediate Release is an investigational small molecule developed by Pfizer, Inc. (ticker PFE). It is also known as PF-06882961 Immediate Release Tablet. The formulation has been studied in a Phase 1 clinical trial in healthy adult subjects, and no approved indication has been disclosed for it.

Who makes PF-06882961 Immediate Release?

PF-06882961 Immediate Release is made and developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer sponsored the Phase 1 formulation study of the immediate release tablet in healthy subjects.

What phase is PF-06882961 Immediate Release in?

PF-06882961 Immediate Release is in Phase 1 development. It is investigational and has not been approved by the FDA. One Phase 1 trial has been completed, and no active trials of this immediate release formulation are currently listed.

What clinical trials is PF-06882961 Immediate Release in?

PF-06882961 Immediate Release has been evaluated in one completed Phase 1 trial, NCT03492697. Titled a single dose crossover study in healthy subjects to evaluate different formulations of PF-06882961, it enrolled 12 healthy adult volunteers in the United States. The study was randomized but uncontrolled and not double blind.

Is PF-06882961 Immediate Release the same as PF-06882961 Immediate Release Tablet?

Yes. PF-06882961 Immediate Release Tablet is another name for PF-06882961 Immediate Release, the Pfizer small molecule formulation studied in the Phase 1 trial NCT03492697. Both names refer to the same immediate release oral product.