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

NCT07455084 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: 384-201-00003
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Schizophrenia

Keywords

Mental Health Conditions, Schizophrenia

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (14)

• Maximum Plasma Concentration (Cmax) of SEP-380135 and Metabolites

  Up to Day 8

• Time for Cmax (tmax) of SEP-380135 and Metabolites

  Up to Day 8

• Area Under the Concentration-Time Curve From Time Zero to the Last Observable Concentration at Time (AUCt) of SEP-380135 and Metabolites

  Up to Day 8

• Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC∞) of SEP-380135 and Metabolites

  Up to Day 8

• Elimination Half-Life (t1/2,z) of SEP-380135 and Metabolites

  Up to Day 8

Study Arms (1)

14C-SEP-380135

EXPERIMENTAL

Participants receive a single oral administration of 14C-SEP-380135 on Day 1.

Drug: 14C-SEP-380135

Interventions

14C-SEP-380135 DRUG

Oral Capsule

14C-SEP-380135

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead

Study Sites (1)

Celerion, Inc.

Lincoln, Nebraska, 68502, United States

Location

Related Links

• Otsuka Clinical Trials website

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Central Study Contacts

Otsuka Call Center

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2026
• First Posted: March 6, 2026
• Study Start: March 20, 2026
• Primary Completion: April 10, 2026
• Study Completion: May 3, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)