This will be an open-label, non-randomized, absorption, metabolism, and excretion study of Lurasidone administered in a suspension at 40 mg to 6 normal healthy male subjects in a postprandial state
A Phase 1 Study to Investigate the Absorption, Metabolism, and Excretion of \[Isothiazolyl-3-14C\]-Lurasidone Following Postprandial Single Oral Dose Administration in Healthy Male Subjects.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
6
40 mg suspension, PO, for 7 days
Covance Global Clinical Research Unit Inc.
Madison, Wisconsin, United States
To assess the pharmacokinetics (PK) of a postprandial single dose of 40 mg (150 Ci 5.55 Megabecquerels (MBq)) [Isothiazolyl-3-14C-Lurasidone and its metabolites
Time frame: 28 days
To determine the whole blood and serum concentrations of total radioactivity of [Isothiazolyl-3-14C]-Lurasidone (150 Ci).
Time frame: 28 days
To determine the urinary and fecal recovery of total radioactivity of [Isothiazolyl-3-14C]-Lurasidone (150 Ci).
Time frame: 28 days
To assess the safety of 40 mg [Isothiazolyl-3-14C]-Lurasidone
Time frame: 28 days
To characterize and identify metabolites of Lurasidone in serum and urine
Time frame: 28 days
To determine serum concentrations of Lurasidone
Time frame: 28 days
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