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

Sponsor ID
384-201-00003
Clinicaltrials.gov ID
NCT07455084
EudraCT ID
N/A
EUCTIS ID
N/A
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information
844-687-8522 or [email protected]
Will Be Recruiting
Sponsor ID
384-201-00003
Trial Details
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Age
18 - 55 Years
Therapeutic Area
  • Schizophrenia
    • Sex
    Male
    Trial Dates
    Mar 2026 - Apr 2026
    Healthy Volunteers
    Yes
    • 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.
    • 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.

    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.

    Additional Study Details

    Phase
    Phase 1
    Study Drug
    Drug: 14C-SEP-380135
    Type
    Interventional
    Masking
    None (Open Label)
    Estimated Enrollment
    8
    Additional Study Details

    Inclusion and Exclusion Criteria

    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:

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

    Locations

    Location
    Status
    Location
    Celerion, Inc.
    Lincoln, Nebraska, United States, 68502
    Status
    N/A

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    January 2026 01US25EUC0489

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