A Study To Establish The Equivalence Of 2 Palbociclib (PD-0332991) Formulations To The Intended Final Market Product

A Phase 1, Open-Label 3 Sequence 3 Period Crossover Study Of Palbociclib (PD-0332991) In Healthy Volunteers To Establish The Bioequivalence Of The Phase 1/2 And Phase 3 Formulation To Palbociclib ICH Formulation Under Fasted Conditions

This study is intended to establish the equivalence of 2 formulations to the intended final market product. The formulations to compare are the capsule given to patients in the phase I and II studies and the capsule that is being administered to the patients in the phase III trials. Both capsules will be compared to the intended final market capsule. The comparison will be performed looking at the pharmacokinetic parameters that define the rate and extent of absorption, those are Cmax and AUC. A statistical analysis will be performed comparing these parameters calculated after a single 125 mg dose of the 3 capsules identifying like that if there are significant differences between these 3 formulations.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: palbociclib capsule: phase 1 and 2 studies; Drug: Palbociclib capsule: phase 3 studies; Drug: Palbociclib capsule: ICH

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Overland Park, Kansas, United States, 66212
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 has been informed of all pertinent aspects of the study.

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Palbociclib given to Healthy Volunteers	Drug: palbociclib capsule: phase 1 and 2 studies; 125 mg dose of palbociclib. Formulation used in phase 1 and 2 studies; Drug: Palbociclib capsule: phase 3 studies; 125 mg dose of palbociclib. Formulation used in phase 3 studies; Drug: Palbociclib capsule: ICH; 125 mg dose of palbociclib. Intended final market formulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	7 days
Maximum Observed Plasma Concentration (Cmax)		7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)	Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)	7 days
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]	AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)	7 days
Area Under the Curve From Time Zero to 72 hrs [AUC (0-72)]	AUC (0-72)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 72 hrs(0-72)	3 days
Apparent Oral Clearance (CL/F)	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.	7 days
Plasma Decay Half-Life (t1/2)	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.	7 days
Apparent Volume of Distribution (Vz/F)	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.	7 days

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (ACTUAL): January 1, 2014
• Study Completion (ACTUAL): January 1, 2014

Study Registration Dates

• First Submitted: July 16, 2013
• First Submitted That Met QC Criteria: July 18, 2013
• First Posted (ESTIMATE): July 23, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): January 20, 2014
• Last Update Submitted That Met QC Criteria: January 17, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: Bioequivalence; AUC; Cmax
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Palbociclib
• Other Study ID Numbers: A5481020