A Study to Detect the Radioactivity of 14C-SEP-380135 in Urine and Feces in Healthy Male Adults (NCT07455084) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Study to Detect the Radioactivity of 14C-SEP-380135 in Urine and Feces in Healthy Male Adults
United States8 participantsStarted 2026-03-20
Plain-language 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.
Who can participate
Age range
18 Years – 55 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing a radioactively labeled version of SEP-380135 specifically to track how the drug leaves the body through urine and feces — since it's Phase 1 and not yet recruiting, what does that mean about how much safety data exists for this drug so far, and should that affect whether I consider it?
2The study is enrolling only healthy male adults to study how the drug is processed and eliminated — given my diagnosis of schizophrenia and my personal health profile, would I even be a candidate, and is there a more appropriate SEP-380135 trial that might be a better fit for someone with my condition?
3Since this trial's main goal is measuring radioactivity levels in urine and feces rather than testing whether the drug actually helps schizophrenia symptoms, how does participating in a study like this differ from one that might offer a direct treatment benefit to me?
4The drug involves exposure to a radioactive carbon tracer (14C) — what are the known or potential risks of that kind of radiation exposure, and are they significant enough to factor into my decision?
5Given that this trial hasn't started recruiting yet, would you recommend I explore standard or currently available treatments for schizophrenia first, and how would participating in this study fit alongside or affect those options?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Total Radioactivity Amount Excreted in Urine (Ae,u)
Timeframe: Up to Day 8
2
Total Radioactivity Amount Excreted in Feces (Ae,f)
Timeframe: Up to Day 8
3
Fraction of Dose Excreted in Urine (%fe,u)
Timeframe: Up to Day 8
4
Fraction of Dose Excreted in Feces (%fe,f)
Timeframe: Up to Day 8
Trial details
NCT IDNCT07455084
SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.
. 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.