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

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NCT01904747

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511 United States
See other locations
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

NCT01904747
Pfizer
Completed
Characterization Of The Effect Of Food On Palbociclib (PD-0332991) Absorption

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

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.
Not Provided
Interventional
Phase 1
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy
  • 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
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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
October 2013
October 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01904747
A5481021
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

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