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Drug Formulation of PD-0332991

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Dec 17, 2013

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment14

FDA Designations

No designations recorded

Clinical trial landscape

Drug Formulation of PD-0332991 · 1 trial · 1 indication

Phase 1 1
NCT01802476A Study Comparing the Plasma Drug Exposure of an Oral Dose of Palbociclib (PD-0332991) to an Intravenous Dose of Palbociclib (PD-0332991)Healthy
COMPLETED14 Analytics
PHASE1COMPLETED
A Study Comparing the Plasma Drug Exposure of an Oral Dose of Palbociclib (PD-0332991) to an Intravenous Dose of Palbociclib (PD-0332991)
Healthy
NCT0180247614
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Study Endpoints

Primary Endpoints

Dose-Normalized Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
0 to 144 hours

Dose-Normalized AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8) divided by the administered dose. It is obtained from AUC (0 - t) plus AUC (t - 8).

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
0 to 144 hours

AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).

Secondary Endpoints

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
0 to 144 hours
Dose-Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
0 to 144 hours
Maximum Observed Plasma Concentration (Cmax)
0 to 144 hours
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Study Design & Arms

MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Fixed Sequence Crossover ArmOTHERThis study arm consists of a fixed sequence crossover where study subjects will receive Treatment A and following a washout of no less than 10 days will then receive Treatment B. The drug class is a CDK4/6 inhibitor.

Interventions

NameTypeDescription
Oral Drug Formulation of PD-0332991DRUGTreatment A consists of a single 125 mg oral dose of PD-0332991.
Intravenous Formulation of PD-0332991DRUGTreatment B consists of a 1000 mL intravenous infusion of 50 mg of PD-0332991 administered over 4 hours at a constant rate.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Healthy male or female of non-childbearing potential between the ages of 18 and 55 years of age. 2. A body mass index (BMI) between 17.5 and 30.5 kg/m2, and a total body weight greater than 50kg (110 lbs) Exclusion Criteria: 1. Any condition which could possibly affect drug...

Countries:United Kingdom
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Frequently asked questions about Drug Formulation of PD-0332991

What is Drug Formulation of PD-0332991 used for?

Drug Formulation of PD-0332991 is a small molecule being studied in healthy volunteers. It is an investigational drug formulation of palbociclib (PD-0332991) that is being evaluated in a Phase 1 clinical trial to compare the plasma drug exposure of an oral dose to an intravenous dose.

Who makes Drug Formulation of PD-0332991?

Drug Formulation of PD-0332991 is being developed by Pfizer, Inc. (NYSE: PFE). The company is conducting a Phase 1 clinical trial of this investigational small molecule formulation in healthy volunteers.

What phase is Drug Formulation of PD-0332991 in?

Drug Formulation of PD-0332991 is in Phase 1 clinical development. It is an investigational drug formulation and is not approved by the FDA. The ongoing Phase 1 trial is designed to compare the plasma drug exposure of an oral dose to an intravenous dose of palbociclib (PD-0332991).

What clinical trials is Drug Formulation of PD-0332991 in?

Drug Formulation of PD-0332991 is being studied in one completed Phase 1 clinical trial, NCT01802476. This trial enrolled 14 healthy volunteers in the United Kingdom and compared the plasma drug exposure of an oral dose of palbociclib (PD-0332991) to an intravenous dose.

Is Drug Formulation of PD-0332991 the same as palbociclib?

Drug Formulation of PD-0332991 is a formulation of palbociclib (PD-0332991). The clinical trial NCT01802476 specifically compares the plasma drug exposure of an oral dose of palbociclib (PD-0332991) to an intravenous dose of palbociclib (PD-0332991), indicating that the drug formulation is being evaluated as a potential alternative delivery method for palbociclib.