The purpose of the study is to investigate the routes of elimination and overall mass balance of 100 mg quemliclustat containing 75 μCi \[14C\] following a single IV infusion of \[14C\]-quemliclustat in healthy adult male participants, and to quantify total radioactivity (TRA) in plasma, whole blood, urine, and feces.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
8
Administered as specified in the treatment arm
Research Site
Lincoln, Nebraska, United States
Percentage of total radioactivity excreted in urine and feces
Time frame: Up to 40 days
Total radioactivity in blood
Time frame: Up to 40 days
Total radioactivity in plasma
Time frame: Up to 40 days
Excretion of total radioactivity in urine
Time frame: Up to 40 days
Excretion of total radioactivity in feces
Time frame: Up to 40 days
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 54 days
Area Under the Curve From 0 to Last Observed Non-zero Concentration (AUC [0-Last]) for quemliclustat
Time frame: Up to 40 days
Area Under the Curve From Time '0' Extrapolated to Infinity (AUC[0-inf]) for quemliclustat
Time frame: Up to 40 days
Maximum Observed Plasma Concentration (Cmax) for quemliclustat
Time frame: Up to 40 days
Elimination Half-life (t1/2) for quemliclustat
Time frame: Up to 40 days
Excretion of quemliclustat in urine
Time frame: Up to 40 days
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