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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01904747
Recruitment Status : Completed
First Posted : July 22, 2013
Last Update Posted : December 17, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Healthy Drug: Palbociclib administered Fasted Drug: Palbociclib administered Fed high calorie Drug: Palbociclib administered Fed low calorie Drug: Palbociclib administered Fed moderate calorie Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official 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
Study Start Date : July 2013
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Palbociclib

Arm Intervention/treatment
Experimental: Palbociclib given to healthy volunteers Drug: Palbociclib administered Fasted
palbociclib given under fasting 10 hrs overnight; capsule form, 125 mg single dose

Drug: Palbociclib administered Fed high calorie
palbociclib given right after a high fat high calorie meal; capsule form, 125 mg single dose

Drug: Palbociclib administered Fed low calorie
palbociclib given right after a low fat low calorie meal; capsule form, 125 mg single dose

Drug: Palbociclib administered Fed moderate calorie
palbociclib given between moderate calorie meal; capsule form, 125 mg single dose




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01904747


Locations
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United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01904747    
Other Study ID Numbers: A5481021
First Posted: July 22, 2013    Key Record Dates
Last Update Posted: December 17, 2013
Last Verified: December 2013
Keywords provided by Pfizer:
Food
Bioavailability
Fasted
Fed
Additional relevant MeSH terms:
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Palbociclib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action