Not Yet RecruitingPhase 1

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

United States8 participantsStarted 2026-03-20

Plain-language summary

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.

Who can participate

Age range18 Years – 55 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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)

Exclusion criteria

✕. 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.

What they're measuring

Total Radioactivity Amount Excreted in Urine (Ae,u)

Timeframe: Up to Day 8

Total Radioactivity Amount Excreted in Feces (Ae,f)

Timeframe: Up to Day 8

Fraction of Dose Excreted in Urine (%fe,u)

Timeframe: Up to Day 8

Fraction of Dose Excreted in Feces (%fe,f)

Timeframe: Up to Day 8

Trial details

NCT IDNCT07455084

SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-04-10

Contact for this trial

Otsuka Call Center

844-687-8522 Otsuka-ProfessionalServices@otsuka-us.com

View on ClinicalTrials.gov More Schizophrenia trials

Who can participate

Age range18 Years – 55 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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)

Exclusion criteria

✕. 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.