The purpose of the present trial is to obtain information on the absorption, distribution, metabolism, excretion and pharmacokinetics (PK) of 14C-SEP-380135 and its metabolites following a single oral dose.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Oral Capsule
Celerion, Inc.
Lincoln, Nebraska, United States
Total Radioactivity Amount Excreted in Urine (Ae,u)
Time frame: Up to Day 8
Total Radioactivity Amount Excreted in Feces (Ae,f)
Time frame: Up to Day 8
Fraction of Dose Excreted in Urine (%fe,u)
Time frame: Up to Day 8
Fraction of Dose Excreted in Feces (%fe,f)
Time frame: Up to Day 8
Maximum Plasma Concentration (Cmax) of SEP-380135 and Metabolites
Time frame: Up to Day 8
Time for Cmax (tmax) of SEP-380135 and Metabolites
Time frame: Up to Day 8
Area Under the Concentration-Time Curve From Time Zero to the Last Observable Concentration at Time (AUCt) of SEP-380135 and Metabolites
Time frame: Up to Day 8
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC∞) of SEP-380135 and Metabolites
Time frame: Up to Day 8
Elimination Half-Life (t1/2,z) of SEP-380135 and Metabolites
Time frame: Up to Day 8
Apparent Clearance of Drug From Plasma After Oral Administration (CL/F) of SEP-380135
Time frame: Up to Day 8
Apparent Clearance of Drug From Plasma After Oral Administration Adjusted for Body Weight (CL/F/BW) of SEP-380135
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Time frame: Up to Day 8
Volume of Distribution Following Oral Administration (Vz/F) of SEP-380135
Time frame: Up to Day 8
Number of Participants with Adverse Events (AEs)
Time frame: Up to Day 31
Number of Participants with Potentially Clinically Significant Changes in Vital Signs
Time frame: Upto Day 8
Number of Participants With Potentially Clinically Significant Changes in Electrocardiogram (ECG) Parameters
Time frame: Upto Day 8
Number of Participants With Potentially Clinically Significant Changes in Physical Examinations
Time frame: Upto Day 8
Number of Participants With Potentially Clinically Significant Changes in Clinical Laboratory Test Parameters
Time frame: Upto Day 8
Number of Participants With Incidence of Suicidal Ideation and Suicidal Behavior Using the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Upto Day 8