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Not yet recruitingPhase 1

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 55 Years
Sex
Male only
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study is for healthy adult men. It tests how the body takes in, breaks down, and clears one dose of 14C-SEP-380135 taken by mouth. It also measures radioactivity from the drug in urine and stool.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a body mass index (BMI), a measure of weight compared with height, between 18.0 and 32.0.
  • Be in good overall health based on health history, exams, heart testing, and blood and urine tests.
  • Have at least one bowel movement each day for 30 days before study Day -2.
  • Be able to give written consent and follow all study instructions.
  • Have a stable place to live when checked for the study and agree to return to a similar living situation after the clinic stay.

Who can't join

  • Took another study drug within 30 days before screening, or longer if that drug takes more time to leave the body.
  • Have received SEP-380135 before.
  • Are taking part in another clinical trial.
  • Attempted suicide within 12 months before screening.
  • Have a history of listed heart problems, including heart attack, certain levels of heart failure, heart muscle disease, abnormal heart rhythms, or fluid buildup in the lungs.
  • Have a personal or family history of long QT, a problem with the heart's electrical signals, or moderately to severely low potassium. Minor heart test changes need approval from the study's medical reviewers.
  • Are expected to have low activity of CYP2D6, a protein that helps the body break down some drugs.
  • Other study rules may also apply.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (1)

NE