Study Of Palbociclib (PD-0332991) In Renal Impairment

Renal Impairment Clinical Trial

Official title:

A Phase 1, Open-label, Single Dose, Parallel-group Study To Evaluate The Pharmacokinetics Of Palbociclib (Pd-0332991) In Subjects With Impaired Renal Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02085538
• Other study ID #: A5481014
• Status: Completed
• Phase: Phase 1
• Start date: May 2014
• Est. completion date: May 2016

Study information

• Verified date: April 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Renal Impairment
• Renal Insufficiency

Intervention

Drug:
• palbociclib
palbociclib 125 mg oral capsule with food once
• palbociclib
palbociclib 125 mg oral capsule with food once
• palbociclib
palbociclib 125 mg oral capsule with food once
• palbociclib
palbociclib 125 mg oral capsule with food once

Locations

Country	Name	City	State
United States	Avail Clinical Research, LLC	DeLand	Florida
United States	Orlando Clinical Research Center	Orlando	Florida
United States	Prism Research	Saint Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	8 days
Primary	Maximum Observed Plasma Concentration (Cmax)		8 days
Secondary	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)	8 days
Secondary	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.	8 days
Secondary	Time to Reach Maximum Observed Plasma Concentration (Tmax)		8 days
Secondary	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.	8 days
Secondary	Plasma Decay Half-Life (t1/2)	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.	8 days
Secondary	Unbound Apparent Oral Clearance (CLu/F)	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.	8 days
Secondary	"Unbound Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)u]"	AUC (0 - 8)u= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8)u for unbound drug. It is obtained from AUC (0 - t)u plus AUC (t - 8)u for unbound drug.	8 days
Secondary	Unbound Maximum Observed Plasma Concentration (Cmaxu)	Cmaxu is the highest measured unbound plasma concentration during the dosing interval.	8 days
Secondary	"Unbound Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClastu)"	Area under the plasma concentration time-curve from zero to the last measured concentration (AUClastu) for unbound drug.	8 days
Secondary	fraction of unbound drug in plasma (fu)	fraction of drug in plasma or tissues that is not bound to plasma or tissue proteins.	8 days
Secondary	Unbound Apparent Volume of Distribution (Vzu/F)	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.	8 days

External Links

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