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

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.

• 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

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