CompletedPhase 1

A Trial to Test the Effects of Other Drugs on SEP-380135 in Healthy Men and Women

United States12 participantsStarted 2025-03-07

Plain-language summary

The purpose of this study is to assess the effect of cytochrome P450 isoenzyme 2D6 (CYP2D6) inhibition by quinidine on the pharmacokinetic (PK) parameters of a single dose SEP-380135 in healthy adult participants.

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

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

. Male or female participants between 18 and 55 years of age (inclusive) at time of consent
. Body mass index from 18.0 to 32.0 kilograms per square meter (kg/m\^2) (inclusive).
. In good health as determined by:
. Medical history
. Physical examination
. Vital signs
. Neurological examination
. Electrocardiogram

Exclusion criteria

. Have taken an investigational drug within 30 days or 5 half-lives, if known, (whichever is longer) prior to screening.
. Have had previous 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.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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

Maximum Observed Concentration (Cmax) of SEP-380135 and its Metabolites

Timeframe: Up to Day 11

Area Under the Curve from Time Zero to Last Measurable Concentration (AUC0-t) of SEP-380135 and its Metabolites

Timeframe: Up to Day 11

Area Under the Curve from Time Zero to Infinity (AUCinfinity) of SEP-380135 and its Metabolites

Timeframe: Up to Day 11

Time to Maximum Concentration (Tmax) of SEP-380135 and its Metabolites

Timeframe: Up to Day 11

Trial details

NCT IDNCT07305779

SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-05-03

View on ClinicalTrials.gov More Schizophrenia trials

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

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

. Male or female participants between 18 and 55 years of age (inclusive) at time of consent
. Body mass index from 18.0 to 32.0 kilograms per square meter (kg/m\^2) (inclusive).
. In good health as determined by:
. Medical history
. Physical examination
. Vital signs
. Neurological examination
. Electrocardiogram

Exclusion criteria

. Have taken an investigational drug within 30 days or 5 half-lives, if known, (whichever is longer) prior to screening.
. Have had previous exposure to SEP-380135.
. Are currently participating in another clinical trial.
. Attempted suicide within 12 months prior to screening.

What they're measuring

Maximum Observed Concentration (Cmax) of SEP-380135 and its Metabolites

Timeframe: Up to Day 11

Area Under the Curve from Time Zero to Last Measurable Concentration (AUC0-t) of SEP-380135 and its Metabolites

Timeframe: Up to Day 11

Area Under the Curve from Time Zero to Infinity (AUCinfinity) of SEP-380135 and its Metabolites

Timeframe: Up to Day 11

Time to Maximum Concentration (Tmax) of SEP-380135 and its Metabolites

Timeframe: Up to Day 11