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Completed

NCT Number: NCT01904747

Characterization Of The Effect Of Food On Palbociclib (PD-0332991) Absorption

This study is intended to quantify the effect of food on the extent of absorption of palbociclib.

The caloric content of the food and the time of the meals with respect to palbociclib administration may influence the capacity of the body to absorb the drug.

High and low calorie meals will be given to the subjects 30 minutes before palbociclib administration as 2 of the 3 conditions to compare with completely absence of food in the body when dosing (fasted).The third condition to test and compare with fasted stage will be the administration of food before and after palbociclib administration.

This information will help the program to decide wether or not the presence of food when dosing palbociclib help with its absorption and to what extent it does help. Based on the collected information, a recommendation about the administration of palbociclib with food will be provided to patients.

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Key information

Conditions

Healthy Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyslipidemias Genetic Diseases, Inborn Hypoalphalipoproteinemias Hypolipoproteinemias Lecithin Cholesterol Acyltransferase Deficiency Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male subjects and/or female subjects of non-childbearing potential between the ages of 18 and 55 years
  • Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study
  • Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures

Exclusion criteria

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
  • Any condition possibly affecting drug absorption
  • Male subjects who are unwilling or unable to use a highly effective method of contraception

Treatment and study plan

Palbociclib administered Fasted

Drug

palbociclib given under fasting 10 hrs overnight; capsule form, 125 mg single dose

Palbociclib administered Fed high calorie

Drug

palbociclib given right after a high fat high calorie meal; capsule form, 125 mg single dose

Palbociclib administered Fed low calorie

Drug

palbociclib given right after a low fat low calorie meal; capsule form, 125 mg single dose

Palbociclib administered Fed moderate calorie

Drug

palbociclib given between moderate calorie meal; capsule form, 125 mg single dose

Primary outcomes

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

    Time frame: 144 hrs

    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).

  2. Maximum Observed Plasma Concentration (Cmax)

    Time frame: 144 hrs

Secondary outcomes

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

    Time frame: 144 hrs

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

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

    Time frame: 144 hrs

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

  3. Area under the Concentration-Time Curve (AUC) from 0 to 72 hrs

    Time frame: 144 hrs

    AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.

  4. Apparent Oral Clearance (CL/F)

    Time frame: 144 hrs

    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.

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

    Time frame: 144 hrs

  6. Apparent Volume of Distribution (Vz/F)

    Time frame: 144 hrs

    Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.

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

    Time frame: 144 hrs

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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase 1, Open-Label 4 Sequence 4 Period Crossover Study Of Palbociclib (PD-0332991) In Healthy Volunteers To Estimate The Effect Of Food On The Bioavailability Of Palbociclib

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jul 22, 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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