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Completed

NCT Number: NCT02085538

Study Of Palbociclib (PD-0332991) In Renal Impairment

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.

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Key information

Conditions

Renal Impairment Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Avail Clinical Research, LLC, DeLand, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Palbociclib

Drug

palbociclib 125 mg oral capsule with food once

Primary outcomes

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

    Time frame: 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).

  2. Maximum Observed Plasma Concentration (Cmax)

    Time frame: 8 days

Secondary outcomes

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

    Time frame: 8 days

    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

  2. Apparent Oral Clearance (CL/F)

    Time frame: 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.

  3. Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Time frame: 8 days

  4. Apparent Volume of Distribution (Vz/F)

    Time frame: 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.

  5. Plasma Decay Half-Life (t1/2)

    Time frame: 8 days

    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

  6. Unbound Apparent Oral Clearance (CLu/F)

    Time frame: 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.

  7. "Unbound Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)u]"

    Time frame: 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.

  8. Unbound Maximum Observed Plasma Concentration (Cmaxu)

    Time frame: 8 days

    Cmaxu is the highest measured unbound plasma concentration during the dosing interval.

  9. "Unbound Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClastu)"

    Time frame: 8 days

    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClastu) for unbound drug.

  10. fraction of unbound drug in plasma (fu)

    Time frame: 8 days

    fraction of drug in plasma or tissues that is not bound to plasma or tissue proteins.

  11. Unbound Apparent Volume of Distribution (Vzu/F)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 13, 2014
Registry last updated
Apr 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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