Otsuka Pharmaceutical Development & Commercialization, Inc.
Phase
Phase 1
Started
2026-03-20
Last updated
2026-03-06
Condition(s) studied
Schizophrenia
Investigational drug(s) / intervention(s)
14C-SEP-380135
14C-SEP-380135: Oral Capsule
Study 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.
Eligibility
Sex
MALE
Min age
18 Years
Max age
55 Years
Healthy volunteers
Accepted
Inclusion Criteria:
1. Body mass index (BMI) between 18.0 and 32.0 kilograms per square meter (kg/m²).
2. In good overall health, based on:
1. Medical history
2. Physical examination
3. Neurological examination
4. Vital signs
5. Electrocardiogram (ECG)
6. Blood and urine tests (serum chemistry, hematology, urinalysis, serology)
3. Regular daily bowel movements (at least one per day) for 30 days before Day -2.
4. Ability to provide written informed consent and follow all study instructions.
5. Has a stable living situation at screening and agrees to return to a similar living arrangement after the in-clinic stay.
Exclusion Criteria:
1. Have taken an investigational drug within 30 days or 5 half-lives, if known, (whichever is longer) prior to screening.
2. Have had prior exposure to SEP-380135.
3. Are currently participating in another clinical trial.
4. Attempted suicide within 12 months prior to screening.
5. 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.
6. Are predicted poor metabolizer CYP2D6 phenotypes. Note: Other protocol-specified inclusion/exclusion criteria may apply.
Primary outcome measure(s)
Total Radioactivity Amount Excreted in Urine (Ae,u) — Up to Day 8
Total Radioactivity Amount Excreted in Feces (Ae,f) — Up to Day 8
Fraction of Dose Excreted in Urine (%fe,u) — Up to Day 8
Fraction of Dose Excreted in Feces (%fe,f) — Up to Day 8
Trial sites (1)
Facility
City
Region
Status
Celerion, Inc.
Lincoln
Nebraska
More Otsuka Pharmaceutical Development & Commercialization, Inc. trials in the USA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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