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Completed

NCT Number: NCT01802476

A Study Comparing the Plasma Drug Exposure of an Oral Dose of Palbociclib (PD-0332991) to an Intravenous Dose of Palbociclib (PD-0332991)

The purpose of this study is to determine approximately what percentage of an orally administered dose of PD-0332991 is absorbed from the gastrointestinal tract into the systemic circulation. This approximation is made by comparing the plasma pharmacokinetics of a 125 mg oral dose of PD-0332991 to the plasma pharmacokinetics of a 50 mg intravenous dose of PD-0332991 administered as a 4-hour infusion.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Nottingham, Nottinghamshire, NG11 6JS, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male or female of non-childbearing potential between the ages of 18 and 55 years of age.
  • 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

  • Any condition which could possibly affect drug absorption.
  • Pregnancy or actively nursing females, or females of childbearing potential.
  • A positive urine drug screen.

Treatment and study plan

Oral Drug Formulation of PD-0332991

Drug

Treatment A consists of a single 125 mg oral dose of PD-0332991.

Intravenous Formulation of PD-0332991

Drug

Treatment B consists of a 1000 mL intravenous infusion of 50 mg of PD-0332991 administered over 4 hours at a constant rate.

Primary outcomes

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

    Time frame: 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).

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

    Time frame: 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 outcomes

  1. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

    Time frame: 0 to 144 hours

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

  2. Dose-Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

    Time frame: 0 to 144 hours

    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) divided by the administered dose.

  3. Maximum Observed Plasma Concentration (Cmax)

    Time frame: 0 to 144 hours

  4. Dose-Normalized Maximum Observed Plasma Concentration (Cmax)

    Time frame: 0 to 144 hours

    The maximum observed plasma concentration divided by the administered dose.

  5. Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Time frame: 0 to 144 hours

  6. Plasma Decay Half-Life (t1/2)

    Time frame: 0 to 144 hours

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

  7. Systemic Clearance (CL)

    Time frame: 0 to 144 hours

    CL is a quantitative measure of the rate at which a drug substance is removed from the body following an intravenous dose.

  8. Apparent Oral Clearance (CL/F)

    Time frame: 0 to 144 hours

    Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.

  9. Apparent Volume of Distribution after an Oral Dose (Vz/F)

    Time frame: 0 to 144 hours

  10. Volume of Distribution at Steady State after an IV Infusion (Vss)

    Time frame: 0 to 144 hours

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase 1, Single Dose, Fixed Sequence, 2-Period Cross-Over Absolute Oral Bioavailability Study In Healthy Volunteers Comparing Oral To Intravenous Administration Of PD-0332991

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Mar 1, 2013
Registry last updated
Dec 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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