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

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT01904747

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

9.3

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Palbociclib administered Fasted Drug: Palbociclib administered Fed high calorie Drug: Palbociclib administered Fed low calorie Drug: Palbociclib administered Fed moderate calorie	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

28 participants

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

Jul 1, 2013

Actual Primary Completion Date :

Oct 1, 2013

Actual Study Completion Date :

Oct 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Palbociclib given to healthy volunteers	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

Arm

Intervention/Treatment

Experimental: Palbociclib given to healthy volunteers

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

Outcome Measures

Primary Outcome Measures

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] [144 hrs]
AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).
Maximum Observed Plasma Concentration (Cmax) [144 hrs]

Secondary Outcome Measures

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [144 hrs]
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] [144 hrs]
AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)
Area under the Concentration-Time Curve (AUC) from 0 to 72 hrs [144 hrs]
AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
Apparent Oral Clearance (CL/F) [144 hrs]
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Time to Reach Maximum Observed Plasma Concentration (Tmax) [144 hrs]
Apparent Volume of Distribution (Vz/F) [144 hrs]
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Plasma Decay Half-Life (t1/2) [144 hrs]
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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