A Phase 1 interventional study of [14C]-PD-0332991 in Healthy, sponsored by Pfizer. Completed at 1 site in United States. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-12-17.
Sponsored by Pfizer · Phase 1, Interventional, and Basic science
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.
Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Radiation: [14C]-PD-0332991
A single 125 mg oral dose of PD-0332991 containing approximately 100 microcurie of \[14C\]-PD-0332991.
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] of PD-0332991
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).
Time frame: 0-192 hrs
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PD-0332991
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
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
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time frame: 0-192hrs
Apparent Oral Clearance (CL/F) of PD-0332991
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.
Time frame: 0-192hrs
Apparent Volume of Distribution (Vz/F) of PD-0332991
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.
Time frame: 0-192hrs
Cumulative radioactivity recovery in urine.
Cumulative radioactivity recovered in urine is the percent of the administered radioactive dose that is observed in the cumulative urine samples.
Time frame: 0-192hrs
Cumulative radioactivity recovery in feces.
Cumulative radioactivity recovered in fecal is the percent of the administered radioactive dose that is observed in the cumulative fecal samples.
Time frame: 0-192hrs
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] of PF-05089326.
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).
Time frame: 0-192hrs
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-05089326.
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
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.
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time frame: 0-192hrs
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] of radioactivity in plasma.
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).
Time frame: 0-192hrs
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of radioactivity in plasma.
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
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.
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time frame: 0-192hrs
Apparent Oral Clearance (CL/F) of radioactivity in plasma.
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.
Time frame: 0-192hrs
Apparent Volume of Distribution (Vz/F) of radioactivity in plasma.
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.
Time frame: 0-192 hrs
This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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