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PF-06412562 tablets_Fasted

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Nov 10, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

PF-06412562 tablets_Fasted · 1 trial · 1 indication

Phase 1 1
NCT02201511A Healthy Volunteer Trial to Gain Information About the Blood Concentrations of PF-06412562 After Oral Administration of a Modified Release Formulation in Fasted and Fed ConditionsHealthy
COMPLETED12 Analytics
PHASE1COMPLETED
A Healthy Volunteer Trial to Gain Information About the Blood Concentrations of PF-06412562 After Oral Administration of a Modified Release Formulation in Fasted and Fed Conditions
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum Observed Plasma Concentration (Cmax)
0-2 days
Time to Reach Maximum Observed Plasma Concentration (Tmax)
0-2 days
Time after dose and before the first plasma concentration (Tlag)
0-2
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf]
0- 2 days

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

Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]
0-2 days

AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)

Plasma Decay Half-Life (t1/2)
0-2 days

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

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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL -
2EXPERIMENTAL -
3EXPERIMENTAL -
4EXPERIMENTAL -

Interventions

NameTypeDescription
3 mg PF-06412562 MR tablets_FastedDRUGA single modified release tablet with 3 mg PF-06412562 administered after an overnight fast
2 x 15 mg PF-06412562 MR tablets_FastedDRUGTwo 15 mg PF-06412562 modified release tablets administered after an overnight fast
2 x 15 mg PF-06412562 MR tablets_FedDRUGTwo 15 mg PF-06412562 modified release tablets administered after a high fat breakfast
10 mg PF-06412562 IR tabletsDRUGa single immediate release tablet of 10 mg PF-06412562 after an overnight fast
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and/or female subjects of non-childbearing 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 pressure and pulse ...

Countries:Belgium
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Frequently asked questions about PF-06412562 tablets_Fasted

What is PF-06412562 tablets_Fasted used for?

PF-06412562 tablets_Fasted is an investigational small molecule being studied in healthy volunteers. It is being evaluated in a Phase 1 clinical trial to gain information about blood concentrations after oral administration of a modified release formulation in fasted and fed conditions. The drug is not approved and remains in clinical development.

Who makes PF-06412562 tablets_Fasted?

PF-06412562 tablets_Fasted is being developed by Pfizer, Inc. (NYSE: PFE). The company is conducting a Phase 1 clinical trial of this investigational small molecule in healthy volunteers.

What phase is PF-06412562 tablets_Fasted in?

PF-06412562 tablets_Fasted is in Phase 1 clinical development. It is an investigational drug and has not been approved. One Phase 1 trial has been completed, with no active trials currently ongoing.

What clinical trials is PF-06412562 tablets_Fasted in?

PF-06412562 tablets_Fasted has one completed clinical trial, NCT02201511, titled "A Healthy Volunteer Trial to Gain Information About the Blood Concentrations of PF-06412562 After Oral Administration of a Modified Release Formulation in Fasted and Fed Conditions." This Phase 1 study enrolled 12 participants in Belgium.

Is PF-06412562 tablets_Fasted the same as PF-06412562?

PF-06412562 tablets_Fasted refers to the modified release tablet formulation of PF-06412562, which is being studied under fasted conditions. The trial NCT02201511 evaluates this formulation in healthy volunteers to assess blood concentrations after oral administration.