Characterization Of The Effect Of Food On Palbociclib (PD-0332991) Absorption
NCT ID: NCT01904747
Last Updated: 2013-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
28 participants
INTERVENTIONAL
2013-07-31
2013-10-31
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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Palbociclib given to healthy volunteers
Palbociclib administered Fasted
palbociclib given under fasting 10 hrs overnight; capsule form, 125 mg single dose
Palbociclib administered Fed high calorie
palbociclib given right after a high fat high calorie meal; capsule form, 125 mg single dose
Palbociclib administered Fed low calorie
palbociclib given right after a low fat low calorie meal; capsule form, 125 mg single dose
Palbociclib administered Fed moderate calorie
palbociclib given between moderate calorie meal; capsule form, 125 mg single dose
Interventions
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Palbociclib administered Fasted
palbociclib given under fasting 10 hrs overnight; capsule form, 125 mg single dose
Palbociclib administered Fed high calorie
palbociclib given right after a high fat high calorie meal; capsule form, 125 mg single dose
Palbociclib administered Fed low calorie
palbociclib given right after a low fat low calorie meal; capsule form, 125 mg single dose
Palbociclib administered Fed moderate calorie
palbociclib given between moderate calorie meal; capsule form, 125 mg single dose
Eligibility Criteria
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Inclusion Criteria
* 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
* Any condition possibly affecting drug absorption
* Male subjects who are unwilling or unable to use a highly effective method of contraception
18 Years
55 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
New Haven, Connecticut, United States
Countries
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References
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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.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A5481021
Identifier Type: -
Identifier Source: org_study_id