SchizophreniaPhase 1NCT07305779
A Trial to Test the Effects of Other Drugs on SEP-380135 in Healthy Men and Women
A Phase 1 study testing SEP-380135 and Quinidine Gluconate in people with Schizophrenia, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- SEP-380135 and Quinidine Gluconate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2025to 3 May 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 11Show fewer
- Neurological examination
- Electrocardiogram
- Serum chemistry, lipid panel, thyroid panel, coagulation panel, urinalysis, hematology, and serology tests (from screening visit).
- 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.
- 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.
Who cannot join
- 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.
- 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.
- In the opinion of the investigator, should not participate in the trial.
- Note: Other protocol-specified inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dr. Vince Clinical Research
Overland Park, Kansas, 66212
About this study
Official title: A Phase 1, Open-label, Single-sequence Pharmacokinetic Trial to Assess the Effect of a Single Oral Dose of SEP-380135 on the Potential for Cytochrome P4502D6 Mediated Drug-drug Interactions in Healthy Adults
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.
- Conditions
- Schizophrenia
- Being tested
- SEP-380135, Quinidine Gluconate
- Keywords
- Mental Health Conditions, Schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SEP-380135Drug
Oral capsules.
Quinidine GluconateDrug
Oral extended-release (ER) tablets.
| Study group | Role | What they receive |
|---|---|---|
| SEP-380135 + Quinidine Gluconate | Experimental | Participants receive SEP-380135 alone on Day 1, followed by administration of quinidine gluconate beginning on Day 6. On Day 7, SEP-380135 is coadministered with quinidine gluconate. Quinidine gluconate dosing continues from Day 8 to Day 10. Receives: Drug: SEP-380135; Drug: Quinidine Gluconate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Concentration (Cmax) of SEP-380135 and its Metabolites
Measured: Up to Day 11
Area Under the Curve from Time Zero to Last Measurable Concentration (AUC0-t) of SEP-380135 and its Metabolites
Measured: Up to Day 11
Area Under the Curve from Time Zero to Infinity (AUCinfinity) of SEP-380135 and its Metabolites
Measured: Up to Day 11
Time to Maximum Concentration (Tmax) of SEP-380135 and its Metabolites
Measured: Up to Day 11
Secondary outcomes (7)
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Measured: Up to 2 months
Number of Participants With Potentially Clinically Significant Changes in Vital Signs
Measured: Up to 2 months
Number of Participants With Potentially Clinically Significant Changes in Electrocardiogram (ECG) Parameters
Measured: Up to 2 months
Number of Participants With Potentially Clinically Significant Changes in Physical Examinations
Measured: Up to 2 months
Number of Participants With Potentially Clinically Significant Changes in Neurological Examinations
Measured: Up to 2 months
Number of Participants With Potentially Clinically Significant Changes in Clinical Laboratory Test Parameters
Measured: Up to 2 months
Number of Participants With Incidence of Suicidal Behavior, Suicidal Ideation and Suicidality Using the Columbia-Suicide Severity Rating Scale (C-SSRS)
Measured: Up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start7 Mar 2025
- Primary completion3 May 2025
- Study completion3 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07305779
- Sponsor's protocol ID
- 384-201-00004
- Status last verified
- Nov 2025
- First submitted
- 12 Dec 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymized individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Single-sequence Pharmacokinetic Trial to Assess the Effect of a Single Oral Dose of SEP-380135 on the Potential for Cytochrome P4502D6 Mediated Drug-drug Interactions in Healthy Adults
- ClinicalTrials.gov ID
- NCT07305779
- Acronym / sponsor ID
- 384-201-00004
- Conditions
- Schizophrenia
- Keywords
- Mental Health Conditions, Schizophrenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Mar 2025 (actual)
- Primary completion
- 3 May 2025 (actual)
- Study completion
- 3 May 2025 (actual)
- First posted
- 26 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SEP-380135 + Quinidine Gluconate | Experimental | Drug: SEP-380135, Drug: Quinidine GluconateParticipants receive SEP-380135 alone on Day 1, followed by administration of quinidine gluconate beginning on Day 6. On Day 7, SEP-380135 is coadministered with quinidine gluconate. Quinidine gluconate dosing continues from Day 8 to Day 10. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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:
- 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.
- 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.
Key exclusion criteria (7 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SEP-380135Oral capsules. | Drug | SEP-380135 + Quinidine Gluconate |
| Quinidine GluconateOral extended-release (ER) tablets. | Drug | SEP-380135 + Quinidine Gluconate |
Primary outcome
Maximum Observed Concentration (Cmax) of SEP-380135 and its Metabolites
Time frame: Up to Day 11
Area Under the Curve from Time Zero to Last Measurable Concentration (AUC0-t) of SEP-380135 and its Metabolites
Time frame: Up to Day 11
Area Under the Curve from Time Zero to Infinity (AUCinfinity) of SEP-380135 and its Metabolites
Time frame: Up to Day 11
Time to Maximum Concentration (Tmax) of SEP-380135 and its Metabolites
Time frame: Up to Day 11
7 secondary outcomes
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 2 months
Number of Participants With Potentially Clinically Significant Changes in Vital Signs
Time frame: Up to 2 months
Number of Participants With Potentially Clinically Significant Changes in Electrocardiogram (ECG) Parameters
Time frame: Up to 2 months
Number of Participants With Potentially Clinically Significant Changes in Physical Examinations
Time frame: Up to 2 months
Number of Participants With Potentially Clinically Significant Changes in Neurological Examinations
Time frame: Up to 2 months
Number of Participants With Potentially Clinically Significant Changes in Clinical Laboratory Test Parameters
Time frame: Up to 2 months
Number of Participants With Incidence of Suicidal Behavior, Suicidal Ideation and Suicidality Using the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: No. Anonymized individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SEP-380135 and Quinidine Gluconate in people with Schizophrenia, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Observed Concentration (Cmax) of SEP-380135 and its Metabolites (time frame: Up to Day 11). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.