About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Body mass index (BMI) between 18.0 and 32.0 kilograms per square meter (kg/m²).
Medical history
Physical examination
Neurological examination
Disqualifiers
Have taken an investigational drug within 30 days or 5 half-lives, if known, (whichever is longer) prior to screening.
Have had prior exposure to SEP-380135.
Are currently participating in another clinical trial.
Attempted suicide within 12 months prior to screening.
Trial design
Single group
Treatments tested in this trial
14C-SEP-380135
DrugOral Capsule
Treatment groups
Trial outcomes
Primary outcomes
Total Radioactivity Amount Excreted in Urine (Ae,u)
Total Radioactivity Amount Excreted in Feces (Ae,f)
Fraction of Dose Excreted in Urine (%fe,u)
Fraction of Dose Excreted in Feces (%fe,f)
Secondary outcomes
Maximum Plasma Concentration (Cmax) of SEP-380135 and Metabolites
Time for Cmax (tmax) of SEP-380135 and Metabolites
Area Under the Concentration-Time Curve From Time Zero to the Last Observable Concentration at Time (AUCt) of SEP-380135 and Metabolites
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC∞) of SEP-380135 and Metabolites
Sponsors and contacts
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