The purpose of this study is to determine how SHP626 is absorbed and excreted from the body in healthy males.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
8
single oral dose 50mg SHP626 with approximately 5.95 μCi RAD
Covance Madison Clinical Research Unit
Madison, Wisconsin, United States
Pharmacokinetic parameters will be determined from the plasma and blood concentration time data of total radioactivity and from the plasma concentration-time data for SHP626 by non-compartmental analysis.
Time frame: Day 1 to day 10
Total radioactivity (RAD) in whole blood and plasma
Time frame: Day 1 to day 10
To determine the total RAD in urine and feces.
Time frame: Day 1 to day 10
Maximum plasma concentration (Cmax) of 50mg [14C]-SHP626 and RAD occurring at time of maximum observed concentration (tmax)
Time frame: Day 1 to day 10
Area under the plasma concentration curve (AUC0-t) of 50mg [14C]-SHP626 and RAD from the time of dosing to the last measurable concentration
Time frame: Day 1 to Day 10
Area under the plasma concentration curve (AUC0-∞ ) of 50mg [14C]-SHP626 and RAD extrapolated to infinity, calculated using the observed value of the last non-zero plasma concentration
Time frame: Day 1 to Day 10
First order rate constant associated with the terminal portion of the plasma curve terminal half-life (t½) for 50mg [14C]-SHP626 and RAD
Time frame: Day 1 to Day 10
Total body clearance (CL/F ) of 50mg [14C]-SHP626 and RAD for extravascular administration divided by the fraction of dose absorbed
Time frame: Day 1-10
Volume of distribution (Vz/F ) of 50mg [14C]-SHP626 and RAD associated with the terminal slope following extra-vascular administration divided by the fraction of dose absorbed
Time frame: Day 1-10
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Cumulative amount (Aef )of RAD recovered in stool over the dosing interval
Time frame: Day 1-10
Excreted Percent of RAD recovered in stool over the dosing interval
Time frame: Day 1-10
Cumulative amount (Aeu ) of RAD recovered in urine over the dosing interval
Time frame: Day 1-10
Excreted Percent of RAD recovered in urine over the dosing interval
Time frame: Day 1-10
Renal Clearance (CLR ) of 50mg [14C]-SHP626
Time frame: Day 1 -10
Characterize and identify metabolites of [14C]-SHP626 in plasma by accelerator mass spectrometry for radioactivity quantification
Metabolites in the excreta and/or plasma will then be structurally identified by a combination of techniques such as co-chromatography with authentic reference standards, high performance liquid chromatography-mass spectrometry, and other spectroscopic techniques if necessary
Time frame: Day 1 to day 10
Characterize and identify metabolites of [14C]-SHP626 in urine by accelerator mass spectrometry for radioactivity quantification
Metabolites in the excreta and/or plasma will then be structurally identified by a combination of techniques such as co-chromatography with authentic reference standards, high performance liquid chromatography-mass spectrometry, and other spectroscopic techniques if necessary
Time frame: Day 1 to day 10
Characterize and identify metabolites of [14C]-SHP626 in feces by liquid scintillation counting
Metabolites in the excreta and/or plasma will then be structurally identified by a combination of techniques such as co-chromatography with authentic reference standards, high performance liquid chromatography-mass spectrometry, and other spectroscopic techniques if necessary
Time frame: Day 1 to day 10
Assess the safety and tolerability of [14C]-SHP626 by adverse events (AEs) defined as changes, including changes from baseline in physical examination findings
AEs will be coded using the agreed upon version of MedDRA. The number of events, incidence, and percentage of TEAEs will be calculated overall, by system organ class and by preferred term. TEAEs will be further summarized by severity and relationship to investigational product. AEs related to investigational product, AEs leading to withdrawal, SAEs, and deaths will be similarly summarized/listed.
Time frame: Screening to day 7
Changes from baseline in vital signs
Time frame: Screening to day 7
Changes from baseline in ECGs
Time frame: Screening to day 7
Changes from baseline in hematology
Time frame: Screening to day 7
Changes from baseline in coagulation
Time frame: Screening to day 7
Changes in baseline in urinalysis
Time frame: Screening to day 7
Changes in baseline in chemistry
Time frame: Screening to day 7