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NCT Number: NCT07455084

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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Celerion, Inc.

Lincoln, Nebraska, 68502, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

14C-SEP-380135

Drug

Oral Capsule

Primary outcomes

  1. Total Radioactivity Amount Excreted in Urine (Ae,u)

    Time frame: Up to Day 8

  2. Total Radioactivity Amount Excreted in Feces (Ae,f)

    Time frame: Up to Day 8

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

    Time frame: Up to Day 8

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

    Time frame: Up to Day 8

Secondary outcomes

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

    Time frame: Up to Day 8

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

    Time frame: Up to Day 8

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

    Time frame: Up to Day 8

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

    Time frame: Up to Day 8

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

    Time frame: Up to Day 8

  6. Apparent Clearance of Drug From Plasma After Oral Administration (CL/F) of SEP-380135

    Time frame: Up to Day 8

  7. Apparent Clearance of Drug From Plasma After Oral Administration Adjusted for Body Weight (CL/F/BW) of SEP-380135

    Time frame: Up to Day 8

  8. Volume of Distribution Following Oral Administration (Vz/F) of SEP-380135

    Time frame: Up to Day 8

  9. Number of Participants with Adverse Events (AEs)

    Time frame: Up to Day 31

  10. Number of Participants with Potentially Clinically Significant Changes in Vital Signs

    Time frame: Upto Day 8

  11. Number of Participants With Potentially Clinically Significant Changes in Electrocardiogram (ECG) Parameters

    Time frame: Upto Day 8

  12. Number of Participants With Potentially Clinically Significant Changes in Physical Examinations

    Time frame: Upto Day 8

  13. Number of Participants With Potentially Clinically Significant Changes in Clinical Laboratory Test Parameters

    Time frame: Upto Day 8

  14. Number of Participants With Incidence of Suicidal Ideation and Suicidal Behavior Using the Columbia-Suicide Severity Rating Scale (C-SSRS)

    Time frame: Upto Day 8

Study contacts

Contact information is provided by the study sponsor or research team.

Otsuka Call Center

CONTACT

[email protected]

844-687-8522

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Industry

Registry information

Official study title

A Phase 1 Trial to Assess the Mass Balance and Pharmacokinetics of a Single Oral Administration of 14C-SEP-380135 in Healthy Male Adults

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 6, 2026
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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