Characterization Of The Effect Of Food On Palbociclib (PD-0332991) Absorption
|ClinicalTrials.gov Identifier: NCT01904747|
Recruitment Status : Completed
First Posted : July 22, 2013
Last Update Posted : December 17, 2013
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 Type :||Interventional (Clinical Trial)|
|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 :||July 2013|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||October 2013|
|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
- Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] [ Time Frame: 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) [ Time Frame: 144 hrs ]
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 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)] [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 144 hrs ]
- Apparent Volume of Distribution (Vz/F) [ Time Frame: 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) [ Time Frame: 144 hrs ]Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01904747
|United States, Connecticut|
|Pfizer Investigational Site|
|New Haven, Connecticut, United States, 06511|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|