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

NCT01904747 | Completed Phase 1

• 1 other identifier: A5481021
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Food; Bioavailability; Fasted; Fed

Outcome Measures

Primary Outcomes (2)

• Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]

  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).

  144 hrs

• Maximum Observed Plasma Concentration (Cmax)

  144 hrs

Secondary Outcomes (7)

• Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

  144 hrs

• Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]

  144 hrs

• Area under the Concentration-Time Curve (AUC) from 0 to 72 hrs

  144 hrs

• Apparent Oral Clearance (CL/F)

  144 hrs

• Time to Reach Maximum Observed Plasma Concentration (Tmax)

  144 hrs

Study Arms (1)

Palbociclib given to healthy volunteers

EXPERIMENTAL

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

Interventions

Palbociclib administered Fasted DRUG

palbociclib given under fasting 10 hrs overnight; capsule form, 125 mg single dose

Palbociclib given to healthy volunteers

Palbociclib administered Fed high calorie DRUG

palbociclib given right after a high fat high calorie meal; capsule form, 125 mg single dose

Palbociclib given to healthy volunteers

Palbociclib administered Fed low calorie DRUG

palbociclib given right after a low fat low calorie meal; capsule form, 125 mg single dose

Palbociclib given to healthy volunteers

Palbociclib administered Fed moderate calorie DRUG

palbociclib given between moderate calorie meal; capsule form, 125 mg single dose

Palbociclib given to healthy volunteers

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Location

Related Publications (1)

• Ruiz-Garcia A, Plotka A, O'Gorman M, Wang DD. Effect of food on the bioavailability of palbociclib. Cancer Chemother Pharmacol. 2017 Mar;79(3):527-533. doi: 10.1007/s00280-017-3246-4. Epub 2017 Feb 15.

  PMID: 28204912 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Lecithin Cholesterol Acyltransferase Deficiency

Condition Hierarchy (Ancestors)

Hypoalphalipoproteinemias; Hypolipoproteinemias; Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2013
• First Posted: July 22, 2013
• Study Start: July 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: December 17, 2013

Record last verified: 2013-12

Locations

US (1)