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

Starting soon · Phase 1

Conditions studied: Schizophrenia

In brief

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.

Key facts

Study ID

NCT07455084

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

8

Starts

2026-03-20

Expected to finish

2026-05-03

Last updated by the study team

2026-03-06

Who can join

Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• 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.
• Are predicted poor metabolizer CYP2D6 phenotypes. Note: Other protocol-specified inclusion/exclusion criteria may apply.

Where it is running

• Celerion, Inc. — Lincoln, Nebraska, United States

Full record on ClinicalTrials.gov

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