Characterization Of The Effect Of Food On Palbociclib Absorption
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 10/19/2013 |
| Start Date: | July 2013 |
| End Date: | October 2013 |
| Contact: | Pfizer CT.gov Call Center |
| Phone: | 1-800-718-1021 |
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.
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
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