The purpose of the study is to measure how the radiolabelled test medicine \[14C\]-Uproleselan (GMI-1271) is taken up, broken down and removed from the body when given intravenously (into a vein) in a group of 6 males. 'Radiolabelled' means that the test medicine has a radioactive component which helps us to track where the drug is in the body. Blood urine and fecal samples will be collected at specific times throughout the study to measure amounts of the test medicine in the body.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
5
\[14C\]-Uproleselan
Quotient Sciences Limited
Ruddington, Nottingham, United Kingdom
Mass Balance Recovery
Urine and feces will be collected at different time points and the radioactivity will be measured. The recovery will be expressed as percentage of radioactivity administered
Time frame: up to 8 days
Tmax
The time from dosing at which Cmax was apparent
Time frame: up to 8 days
Cmax
maximum observed concentration
Time frame: up to 8 days
AUC(0-last)
area under the curve from 0 time to last measurable concentration
Time frame: up to 8 days
AUC(0-inf)
area under the curve from 0 time extrapolated to infinity
Time frame: up to 8 days
AUC%extrap
percentage of AUC(0-inf) extrapolated beyond last measured time point
Time frame: up to 8 days
lambda-z
the apparent elimination rate constant
Time frame: up to 8 days
T1/2
the apparent elimination half-life
Time frame: up to 8 days
CI
clearance, the apparent volume cleared of parent drug per unit time after intravenous administration
Time frame: up to 8 days
Vx
the apparent volume of distribution after intravenous administration
Time frame: up to 8 days
MRT
mean residence time
Time frame: up to 8 days
Ae(urine)
the amount of Uproleselan excreted in the urine expressed as a percentage of the administered dose
Time frame: up to 8 days
%Ae(urine)
the amount of Uproleselan excreted in the urine expressed as a percentage of the administered dose
Time frame: up to 8 days
CLr
renal clearance: the apparent volume of plasma cleared of Uproleselan per unit time via renal elimination, calculated as: CLr = Ae (urine) / AUC
Time frame: up to 8 days
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