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

Study Identifier:
384-201-00003
ClinicalTrials.gov Identifier:
NCT07455084
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information:
844-687-8522 or [email protected]
Will Be Recruiting
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Study Details

Medical Condition
  • Schizophrenia
Study Drug
  • Drug: 14C-SEP-380135
Date
Mar 2026 - Apr 2026
Phase 1/2
Phase 2/3
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Male
Age: 18 - 55 Years
Requirements Information
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.

Protocol 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.

Study Locations

Location
Status
Location
Celerion, Inc.
Lincoln, Nebraska, United States, 68502
Status
N/A
© 2025 Otsuka America Pharmaceutical,
Inc All rights reserved.

July 2025 01US25EUC0279

Requirements information
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.

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