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A Single-Radiolabeled Dose Mass Balance Study To Investigate The Absorption, Metabolism, And Excretion Of [14C] Palbociclib (PD-0332991) In Healthy Male Volunteers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01756768
First Posted: December 27, 2012
Last Update Posted: December 17, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
December 20, 2012
December 27, 2012
December 17, 2013
January 2013
March 2013   (Final data collection date for primary outcome measure)
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] of PD-0332991 [ Time Frame: 0-192 hrs ]
    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).
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PD-0332991 [ Time Frame: 0-192hrs ]
    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
  • Maximum Observed Plasma Concentration (Cmax) of PD-0332991 [ Time Frame: 1-24hrs ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) of PD-0332991 [ Time Frame: 1-24hrs ]
  • Plasma Decay Half-Life (t1/2) of PD-0332991 [ Time Frame: 0-192hrs ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
  • Apparent Oral Clearance (CL/F) of PD-0332991 [ Time Frame: 0-192hrs ]
    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) of PD-0332991 [ Time Frame: 0-192hrs ]
    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.
  • Cumulative radioactivity recovery in urine. [ Time Frame: 0-192hrs ]
    Cumulative radioactivity recovered in urine is the percent of the administered radioactive dose that is observed in the cumulative urine samples.
  • Cumulative radioactivity recovery in feces. [ Time Frame: 0-192hrs ]
    Cumulative radioactivity recovered in fecal is the percent of the administered radioactive dose that is observed in the cumulative fecal samples.
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] of PD-0332991 [ Time Frame: 0-192 hrs ]
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PD-0332991 [ Time Frame: 0-192hrs ]
  • Maximum Observed Plasma Concentration (Cmax) of PD-0332991 [ Time Frame: 1-24hrs ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) of PD-0332991 [ Time Frame: 1-24hrs ]
  • Plasma Decay Half-Life (t1/2) of PD-0332991 [ Time Frame: 0-192hrs ]
  • Apparent Oral Clearance (CL/F) of PD-0332991 [ Time Frame: 0-192hrs ]
  • Apparent Volume of Distribution (Vz/F) of PD-0332991 [ Time Frame: 0-192hrs ]
  • Cumulative radioactivity recovery in urine. [ Time Frame: 0-192hrs ]
  • Cumulative radioactivity recovery in feces. [ Time Frame: 0-192hrs ]
Complete list of historical versions of study NCT01756768 on ClinicalTrials.gov Archive Site
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] of PF-05089326. [ Time Frame: 0-192hrs ]
    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).
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-05089326. [ Time Frame: 0-192hrs ]
    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
  • Maximum Observed Plasma Concentration (Cmax) of PF-05089326. [ Time Frame: 0-192hrs ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05089326. [ Time Frame: 0-192hrs ]
  • Plasma Decay Half-Life (t1/2) of PF-05089326. [ Time Frame: 0-192hrs ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] of radioactivity in plasma. [ Time Frame: 0-192hrs ]
    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).
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of radioactivity in plasma. [ Time Frame: 0-192hrs ]
    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
  • Maximum Observed Concentration (Cmax) of radioactivity in plasma. [ Time Frame: 0-192hrs ]
  • Time to Reach Maximum Observed Concentration (Tmax) of radioactivity in plasma. [ Time Frame: 0-192hrs ]
  • Plasma Decay Half-Life (t1/2) of radioactivity in plasma. [ Time Frame: 0-192hrs ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
  • Apparent Oral Clearance (CL/F) of radioactivity in plasma. [ Time Frame: 0-192hrs ]
    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) of radioactivity in plasma. [ Time Frame: 0-192 hrs ]
    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.
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] of PF-05089326. [ Time Frame: 0-192hrs ]
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-05089326. [ Time Frame: 0-192hrs ]
  • Maximum Observed Plasma Concentration (Cmax) of PF-05089326. [ Time Frame: 0-192hrs ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05089326. [ Time Frame: 0-192hrs ]
  • Plasma Decay Half-Life (t1/2) of PF-05089326. [ Time Frame: 0-192hrs ]
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] of radioactivity in plasma. [ Time Frame: 0-192hrs ]
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of radioactivity in plasma. [ Time Frame: 0-192hrs ]
  • Maximum Observed Concentration (Cmax) of radioactivity in plasma. [ Time Frame: 0-192hrs ]
  • Time to Reach Maximum Observed Concentration (Tmax) of radioactivity in plasma. [ Time Frame: 0-192hrs ]
  • Plasma Decay Half-Life (t1/2) of radioactivity in plasma. [ Time Frame: 0-192hrs ]
  • Apparent Oral Clearance (CL/F) of radioactivity in plasma. [ Time Frame: 0-192hrs ]
  • Apparent Volume of Distribution (Vz/F) of radioactivity in plasma. [ Time Frame: 0-192 hrs ]
Not Provided
Not Provided
 
A Single-Radiolabeled Dose Mass Balance Study To Investigate The Absorption, Metabolism, And Excretion Of [14C] Palbociclib (PD-0332991) In Healthy Male Volunteers
A Phase One Open-Label Single-Radiolabeled Dose Study To Investigate The Absorption, Metabolism, And Excretion Of [14C] PD-0332991 In Healthy Male Volunteers
This will be an open-label, single-center study to evaluate the mass-balance and pharmacokinetics of PD-0332991 in approximately 6 healthy male subjects receiving a single oral 125 mg dose of PD-0332991 containing approximately 100 microcuries of [14C]-PD-0332991. Subjects will be checked in to the research unit from approximately 12 hours prior to dosing and remain in house until greater than 90% of the administered radioactivity is collected from bodily excreta or until less than 1% of the administered radioactivity is recovered from excreta on consecutive days. This study will investigate the extent of involvement of the renal and hepatic systems in the elimination of PD-0332991 and will seek to identify the compound's major metabolites.
Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy
Radiation: [14C]-PD-0332991
A single 125 mg oral dose of PD-0332991 containing approximately 100 microcurie of [14C]-PD-0332991.
Experimental: Radio-labeled Dose Arm
Intervention: Radiation: [14C]-PD-0332991
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
March 2013
March 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • A Healthy Male Volunteer between 18 and 55 years of age inclusive
  • A Body Mass Index (BMI) of 17.5 to 30.5 kg/m2 and a total body weight >50kg
  • A signed informed consent document

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular,hepatic,psychiatric, neurologic, or allergic disease.
  • A positive urine drug or urine cotinine screen.
  • Concurrent use of herbal or prescription medications or treatment with an investigational drug within 30 days or 5 half-lives preceding first dose of study medication.
  • Subjects whose occupation requires exposure to radiation or monitoring of radiation exposure.
  • Subjects with a history of irregular bowel movements (eg, regular episodes of diarrhea or constipation, irritable bowel syndrome (IBS) or lactose intolerance).
Sexes Eligible for Study: Male
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01756768
A5481011
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP