The study aims to understand, using radiolabelled PF-04449913, how this compound is modified by the body once it is absorbed. The study also aims to understand how much of the compound is broken down and how much leaves the body unchanged.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
6
Single oral dose of 100 mg PF-04449913 + 100µCi of \[14C\] PF-04449913
Pfizer Investigational Site
Madison, Wisconsin, United States
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).
Time frame: 7 days
Maximum Observed Plasma Concentration (Cmax)
Time frame: 7 days
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] for total radioactivity related to drug product
AUC (0 - 8)= Area under the plasma radioactivity 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: 7 days
Maximum Observed Plasma Concentration (Cmax) for total radioactivity related to drug product
Time frame: 7 days
Cumulative recovery of radioactivity in excreta
Total percentage of dosed radioactivity recovered in urine and feces
Time frame: 7 days
Radioactivity in blood
Total percentage of radioactivity in blood related to drug product
Time frame: 7 days
Urine PF-04449913 PK parameters
Measure of renal clearance (CLr), amount excreted unchanged in urine (Ae) and the fraction of dose excreted unchanged in urine (AE%)
Time frame: 7 days
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
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Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Time frame: 7 days
Plasma Decay Half-Life (t1/2)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time frame: 7 days
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.
Time frame: 7 days
Apparent Volume of Distribution (Vz/F)
plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Time frame: 7 days