Relative Bioavailability Of Palbociclib (PD-0332991) Under Fed And Fasted Conditions

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: palbociclib isethionate (phase 1 and 2 studies); Drug: palbociclib commercial free base capsule

• Registration Number: NCT02041273
• Lead Sponsor: Pfizer

Brief Summary

A relative bioavailability study of commercial palbociclib free base hard capsules to the isethionate salt palbociclib capsules ( used in Phase 1 and 2 studies) under different fasting conditions.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-14
• Study First Submitted QC: 2014-01-21
• Study First Posted: 2014-01-22
• Status Verified: 2014-03
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Last Update Submitted: 2014-03-14
• Last Update Posted: 2014-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Palbociclib given to healthy volunteers	palbociclib commercial free base capsule	-
Palbociclib given to healthy volunteers	palbociclib isethionate (phase 1 and 2 studies)	-

Primary Outcome Measures

Name	Time	Method
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]	7 days	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)	7 days

Secondary Outcome Measures

Name	Time	Method
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)	7 days	Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Apparent Oral Clearance (CL/F)	7 days	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.
Plasma Decay Half-Life (t1/2)	7 days	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Apparent Volume of Distribution (Vz/F)	7 days	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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 New Haven, Connecticut, United States