This is a Phase 1, open-label non-randomized, single dose study in healthy male subjects.
This is a Phase 1, open-label nonrandomized, single dose study in healthy male subjects to determine the absorption, metabolism, and excretion (AME) of \[14C\]-PBI-200
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
\[14C\]-radio-labeled-PBI-200
Labcorp Clinical Research Unit Inc
Madison, Wisconsin, United States
Total Radioactivity in Urine and Feces
Time frame: 28 days
Area Under the Concentration-Time Curve (AUC) of PBI-200 from time zero to infinity [AUC(0-inf)]
Time frame: 28 days
Area Under the Concentration-Time Curve (AUC) of PBI-200 from time zero to the time of the last quantifiable concentration [AUC(0-tlast)
Time frame: 28 days
Maximum Observed Concentration [C(max)]
Time frame: 28 days
Time to Maximum Concentration [T(max)]
Time frame: 28 days
Apparent Terminal Elimination Half-life [t(1/2)]
Time frame: 28 days
Total Radioactivity in Plasma and Whole Blood
Time frame: 28 days
Ratio for AUC(0-inf) Blood / Plasma
Time frame: 28 days
Ratio for AUC(0-inf) Plasma PBI-200 / Total Radioactivity
Time frame: 28 days
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