This is a Phase 1, open-label, nonrandomized, single-dose mass balance and metabolite identification study in healthy male subjects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
7
a single oral dose of \[14C\]-KBP-5074
Covance Clinical Research Unit Inc.
Madison, Wisconsin, United States
Mass Balance of KBP-5074
Percentage of total radioactivity recovered in urine and feces following a single dose \[14C\]-KBP-5074
Time frame: up to 240 hours postdose
Pharmacokinetic Parameter: Area under the concentration-time curve from time 0 to infinity (AUC0-∞)
Area under the concentration-time curve from time 0 to infinity (AUC0-∞) - Plasma
Time frame: up to 216 hours postdose
Pharmacokinetic Parameter: Area under the plasma concentration time curve from time zero to time of last quantifiable concentration (AUC0-tlast)
Area under the plasma concentration time curve from time zero to time of last quantifiable concentration (AUC0-tlast) - Plasma
Time frame: up to 216 hours postdose
Pharmacokinetic Parameter: Time of the maximum observed concentration (Cmax)
Time of the maximum observed concentration (Cmax) - Plasma
Time frame: up to 216 hours postdose
Metabolite radioprofiling and identification in plasma, urine and feces
Select plasma, urine, and fecal samples will be processed and subject to metabolite analysis by LC/MS \& LC/MS/MS using high-resolution mass spectrometry.
Time frame: up to 240 hours postdose
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