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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Palbociclib administered Fasted; Drug: Palbociclib administered Fed high calorie; Drug: Palbociclib administered Fed low calorie; Drug: Palbociclib administered Fed moderate calorie

Study type: Interventional

Funder types: Industry

Identifiers

NCT01904747

A5481021

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

28 participants in 1 patient group

Palbociclib given to healthy volunteers

Experimental group

Treatment:

Drug: Palbociclib administered Fed high calorie

Drug: Palbociclib administered Fasted

Drug: Palbociclib administered Fed low calorie

Drug: Palbociclib administered Fed moderate calorie