New schizophrenia drug put through interaction test in 12 volunteers
NCT ID NCT07305779
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This completed phase 1 trial enrolled 12 healthy adults to see how a single dose of the experimental schizophrenia drug SEP-380135 interacts with quinidine, a medicine that blocks a key liver enzyme. Researchers measured drug levels in the blood and monitored safety. The goal is to understand how other drugs might affect SEP-380135's breakdown, guiding future dosing in patients.
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 (oral capsule) and quinidine gluconate (oral tablet)
- What this could lead to
- If successful, this study will help determine safe dosing for SEP-380135 when taken with other medications that affect the same liver enzyme.
- What could go wrong
- This is a very early, small study in healthy people, not patients. It only looks at drug interactions, not whether SEP-380135 works for schizophrenia. Results may not predict real-world effects.
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
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
12 people
The number who actually took part.
- Started
-
Mar 2025
- Finished
-
May 2025
- Lead sponsor
-
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
-
18 to 55 years
- Sex
-
Anyone
- Healthy volunteers
-
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. Male or female participants between 18 and 55 years of age (inclusive) at time of consent 2. Body mass index from 18.0 to 32.0 kilograms per square meter (kg/m\^2) (inclusive). 3. In good health as determined by: 1. Medical history 2. Physical examination 3. Vital signs 4. Neurological examination 5. Electrocardiogram 6. Serum chemistry, lipid panel, thyroid panel, coagulation panel, urinalysis, hematology, and serology tests (from screening visit). 4. Willing to stay in the clinic for the required period (i.e., to be hospitalized for 10 days) and willing to be contacted for the safety follow-up telephone call. 5. Ability to provide written, informed consent prior to initiation of any trial-related procedures, and ability, in the opinion of the Principal Investigator, to comply with all the requirements of the trial. 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 previous 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, first-, second-, or third-degree atrioventricular block, myocardial infarction, New York Heart Association Class II-IV heart failure, cardiomyopathy, pulmonary congestion, cardiac arrhythmia, 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. In the opinion of the investigator, should not participate in the trial. 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.
Contacts and locations
Locations
-
Dr. Vince Clinical Research
Overland Park, Kansas, 66212, United States
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