Status:
COMPLETED
Characterization Of The Effect Of Food On Palbociclib (PD-0332991) Absorption
Lead Sponsor:
Pfizer
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01904747
Start Date
July 1 2013
End Date
October 1 2013
Last Update
December 17 2013
Active Locations (1)
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1
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511