Tiny study tracks experimental schizophrenia Drug's journey in healthy men
NCT ID NCT07455084
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial will give 8 healthy men a single dose of a radioactive-labeled experimental drug called SEP-380135, which is being developed for schizophrenia. The goal is to track how the drug is absorbed, broken down, and eliminated from the body. This study does not test whether the drug works; it only gathers basic information needed for future research.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SEP-380135 (a radioactive-labeled experimental drug)
- What this could lead to
- If successful, this study will help researchers understand how SEP-380135 moves through the body, which is a necessary step toward developing a potential treatment for schizophrenia.
- What could go wrong
- This is a very early, small study in just 8 healthy men, not people with schizophrenia. It only measures drug processing, not whether the drug works or is safe long-term. The radioactive label is safe at these levels but adds a minor risk.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 8 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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May 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 55 years
- Sex
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Male participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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: 1. Medical history 2. Physical examination 3. Neurological examination 4. Vital signs 5. Electrocardiogram (ECG) 6. Blood and urine tests (serum chemistry, hematology, urinalysis, serology) 3. Regular daily bowel movements (at least one per day) for 30 days before Day -2. 4. Ability to provide written informed consent and follow all study instructions. 5. Has a stable living situation at screening and agrees to return to a similar living arrangement after the in-clinic stay. 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. 3. Are currently participating in another clinical trial. 4. Attempted suicide within 12 months prior to screening. 5. 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. 6. Are predicted poor metabolizer CYP2D6 phenotypes. Note: Other protocol-specified inclusion/exclusion criteria may apply.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Celerion, Inc.
Lincoln, Nebraska, 68502, United States
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Other studies related to the condition(s) this trial covers.
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- Five-Year safety check for experimental schizophrenia drug