A Study to Detect the Radioactivity of 14C-SEP-380135 in Urine and Feces in Healthy Male Adults

Korábbi kezelés

• 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.
• Attempted suicide within 12 months prior to screening.

Laborértékek

• A history of sick sinus syndrome, any degree of atrioventricular block, Heart attack (myocardial infarction), heart failure (NYHA Class II-IV), cardiomyopathy, pulmonary congestion, cardiac arrhythmias, prolonged QT interval, congenital long QT syndrome, family history of long QT, or moderate to severe hypokalemia. A participant with non-clinically significant ECG abnormalities at screening and check-in requires approval from the medical monitor and the sponsor's physician.

Egyéb

• Are currently participating in another clinical trial.
• Are predicted poor metabolizer CYP2D6 phenotypes. Note: Other protocol-specified inclusion/exclusion criteria may apply.

• Body mass index (BMI) between 18.0 and 32.0 kilograms per square meter (kg/m²).
• In good overall health, based on:
  • Medical history
  • Physical examination
  • Neurological examination
  • Vital signs
  • Electrocardiogram (ECG)
  • Blood and urine tests (serum chemistry, hematology, urinalysis, serology)
• Regular daily bowel movements (at least one per day) for 30 days before Day -2.
• Ability to provide written informed consent and follow all study instructions.
• Has a stable living situation at screening and agrees to return to a similar living arrangement after the in-clinic stay.