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

NCT01904747 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2013-12-17

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01904747 on ClinicalTrials.gov