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PF-06882961 Immediate Release

Phase 1

Healthy Subjects | Small molecule | Other |Pfizer, Inc.|Last Updated: Jul 30, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED

Total Trials1

Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

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 Subjects

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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

Arm	Type	Description
PF-06882961	EXPERIMENTAL	-

Interventions

Name	Type	Description
PF-06882961 Immediate Release Tablet	DRUG	Immediate Release Tablet
PF-06882961 Controlled Release Tablet (long)	DRUG	Controlled Release tablet (long)
PF-06882961 Controlled Release Tablet (short)	DRUG	Controlled Release tablet (short)
PF-06882961 Immediate Release Solution	DRUG	PF-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 used for?

PF-06882961 Immediate Release is an investigational small molecule being studied in healthy subjects. It is intended for research purposes only and is not approved for any medical condition. The drug is currently in Phase 1 clinical development.

Who makes PF-06882961 Immediate Release?

PF-06882961 Immediate Release is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The company is conducting clinical trials to evaluate this investigational drug.

What phase is PF-06882961 Immediate Release in?

PF-06882961 Immediate Release is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied in healthy subjects to evaluate different formulations.

What clinical trials is PF-06882961 Immediate Release in?

PF-06882961 Immediate Release is being studied in clinical trial NCT03492697, a single dose crossover study in healthy subjects to evaluate different formulations of the drug. This Phase 1 trial was completed in the United States and enrolled 12 participants.

Is PF-06882961 Immediate Release FDA approved?

PF-06882961 Immediate Release is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The drug is being studied in healthy subjects, and its safety and efficacy have not been established for any medical use.