This is a phase 1 study to assess the routes of elimination of a single oral dose of \[14C\] PF-00868554 and to characterize the metabolic profile following single dose administration.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
7
solution, single dose
Pfizer Investigational Site
Tacoma, Washington, United States
The amount of radioactivity recovered in urine and feces, as a percent of the dose.
Time frame: 7 weeks
The amount of PF-00868554, expressed as a percent of total radioactivity, in plasma, urine, and feces.
Time frame: 7 weeks
Identification and determination of relative abundance of the metabolites of PF-00868554 in plasma, urine, and feces.
Time frame: 7 weeks
PK parameters: AUClast, AUCinf, maximum concentration (Cmax), time of maximum concentration (Tmax), and half-life (t1/2) to describe the single dose PK of a) total radioactivity in blood; b) total radioactivity in plasma; c) PF-00868554 in plasma.
Time frame: 7 weeks
Safety endpoints including adverse events, clinical laboratory tests, vital signs and ECGs.
Time frame: 7 weeks
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