An Open-Label, Single-Dose, Mass-Balance Study to Assess the Absorption, Metabolism, and Excretion of Radio Labeled SPN-810M in Healthy Adult Male Volunteers
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
Quotient Clinical
Ruddington, Nottingham, United Kingdom
Urinary and fecal recoveries (mass balance) of total radioactivity.
C(urine and feces), Ae(urine and feces), CumAe(urine and feces), % Dose(urine and feces), CUM% Dose(urine and feces).
Time frame: 10 days post dose.
Whole blood and plasma partitioning of total radioactivity.
To determine whole blood and plasma partitioning of total radioactivity
Time frame: 10 days post dose.
Pharmacokinetics (PK) of total radioactivity in plasma.
PK of total radioactivity in plasma (Cmax, Tmax, AUC0-t, AUCinf, Kel, and t1/2).
Time frame: 10 days post dose.
PK of SPN-810 in plasma.
PK of SPN-810 in plasma (Cmax, Tmax, AUC0-t, AUCinf, Kel, and t1/2).
Time frame: 10 days post dose.
PK of the major metabolites of SPN-810 in plasma.
PK of the major metabolites of SPN-810 in plasma (Cmax, Tmax, AUC0-t, AUCinf, Kel, and t1/2).
Time frame: 10 days post dose.
Metabolites of SPN-810 in plasma, urine and feces
To characterize and identify the metabolites of SPN-810 in plasma, urine and feces.
Time frame: 10 days post dose.
Safety and tolerability of SPN-810.
To assess the safety and tolerability of SPN-810 by collecting Adverse Events.
Time frame: 10 days post dose.
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