ITI-1284-012 is an open-label, single-dose study to assess the mass balance recovery of radioactivity, and to evaluate the pharmacokinetics, safety and tolerability of ITI-1284 after a single subcutaneous dose of \[14C\]-ITI-1284 in healthy male subjects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
\[14C\]-ITI-1284 20 mg oral solution (not more than 22 μCi), subcutaneous administration
Clinical Site 1
Nottingham, United Kingdom
Mass balance recovery of total radioactivity in urine and feces combined
percentage of total radioactivity
Time frame: Day 1 up to Day 29
Pharmacokinetics: AUC0-t for total radioactivity
Area under the plasma drug concentration-time curve (AUC) from time zero to the last measurable concentration
Time frame: Day 1 up to Day 29
Pharmacokinetics: AUC0-t for ITI-1284
Area under the plasma drug concentration-time curve (AUC) from time zero to the last measurable concentration
Time frame: Day 1 to Day 8
Pharmacokinetics: Cmax for total radioactivity
Maximum plasma concentration
Time frame: Day 1 up to Day 29
Pharmacokinetics: Cmax for ITI-1284
Maximum plasma concentration
Time frame: Day 1 to Day 8
Pharmacokinetics: Tmax for total radioactivity
Time of maximum plasma concentration
Time frame: Day 1 up to Day 29
Pharmacokinetics: Tmax for ITI-1284
Time of maximum plasma concentration
Time frame: Day 1 to Day 8
Percentage of subjects with treatment-emergent adverse events
Time frame: Up to 30 days after the dose of study drug
Change from baseline in systolic and diastolic blood pressure
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Time frame: Day 14
Change from baseline in ECG QT interval
Time frame: Day 14