Study Of Palbociclib (PD-0332991) In Renal Impairment

Phase 1

Completed

• Conditions: Renal Impairment
• Interventions: Drug: palbociclib

• Registration Number: NCT02085538
• Lead Sponsor: Pfizer

Brief Summary

Since the amount of palbociclib eliminated in urine is 6.9%, renal impairment is not expected to have much impact on palbociclib. However, the Federal Drug Administration (FDA) Guidance recommends a study in subjects with renal impairment when the drug is likely to be used in patients with impaired renal function. Palbociclib is intended for chronic use in cancer patients who may have some degree of impaired renal function.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-11
• Study First Submitted QC: 2014-03-11
• Study First Posted: 2014-03-13
• Study Start: 2014-05
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-26
• Last Update Posted: 2018-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

• Personally signed and dated informed consent document.
• Renal function calculated by the Cockcroft Gault equation: normal function (CLcr >=90 mL/min), mild: CLcr >=60 mL/min and <90 mL/min, moderate: CLcr >=30 mL/min and <60 mL/min, severe: CLcr <30 mL/min but not requiring hemodialysis.
• Subjects with normal renal function matched for age, weight, gender and race to subjects in impaired renal function groups.

Exclusion Criteria

• Any condition possibly affecting drug absorption.
• Renal allograft recipients.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal Renal Function	palbociclib	-
Mild Renal Impairment	palbociclib	-
Moderate Renal Impairment	palbociclib	-
Severe Renal Impairment	palbociclib	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Time to Reach Maximum Observed Plasma Concentration (Tmax)	8 days
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)	8 days	Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Apparent Oral Clearance (CL/F)	8 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.
Apparent Volume of Distribution (Vz/F)	8 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.
Plasma Decay Half-Life (t1/2)	8 days	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Unbound Maximum Observed Plasma Concentration (Cmaxu)	8 days	Cmaxu is the highest measured unbound plasma concentration during the dosing interval.
Unbound Apparent Oral Clearance (CLu/F)	8 days	Clearance of unbound 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 oral bioavailability. Unbound drug clearance is a quantitative measure of the rate at which an unbound drug substance is removed from the blood.
"Unbound Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)u]"	8 days	AUC (0 - ∞)u= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞)u for unbound drug. It is obtained from AUC (0 - t)u plus AUC (t - ∞)u for unbound drug.
"Unbound Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClastu)"	8 days	Area under the plasma concentration time-curve from zero to the last measured concentration (AUClastu) for unbound drug.
fraction of unbound drug in plasma (fu)	8 days	fraction of drug in plasma or tissues that is not bound to plasma or tissue proteins.
Unbound Apparent Volume of Distribution (Vzu/F)	8 days	Unbound Volume of distribution is defined as the theoretical volume in which the total unbound amount of drug would need to be uniformly distributed to produce the desired unbound plasma concentration of a drug. Unbound Apparent volume of distribution after oral dose (Vzu/F) is influenced by the fraction absorbed.

Trial Locations

Locations (3)

Orlando Clinical Research Center; 🇺🇸 Orlando, Florida, United States

Avail Clinical Research, LLC; 🇺🇸 DeLand, Florida, United States

Prism Research; 🇺🇸 Saint Paul, Minnesota, United States