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

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NCT01904747

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Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511, United States
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Characterization Of The Effect Of Food On Palbociclib (PD-0332991) Absorption
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: Palbociclib given to healthy volunteers
Interventions:
  • Drug: Palbociclib administered Fasted
  • Drug: Palbociclib administered Fed high calorie
  • Drug: Palbociclib administered Fed low calorie
  • Drug: Palbociclib administered Fed moderate calorie
Publications * Ruiz-Garcia A, Plotka A, O'Gorman M, Wang DD. Effect of food on the bioavailability of palbociclib. Cancer Chemother Pharmacol. 2017 Mar;79(3):527-533. doi: 10.1007/s00280-017-3246-4. Epub 2017 Feb 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 17, 2013)		28
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01904747
Other Study ID Numbers  ICMJE A5481021
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP