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New schizophrenia drug put through interaction test in 12 volunteers

NCT ID NCT07305779

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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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