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CompletedNCT07305779Updated Jan 15, 2026

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

A Phase 1 interventional study of SEP-380135 and Quinidine Gluconate in Schizophrenia, sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-15.

Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was May 2025, 1 year 5 months ago, and no results have been posted to the registry.
  • Registered 9 months after the study started (first participant enrolled Mar 2025, registered Dec 2025).
Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Non-randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Schizophrenia

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Keywords

  • Mental Health Conditions
  • Schizophrenia
03

In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's enrollment of 12 is below the median of 70 across 2,872 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc. is the lead sponsor of 289 studies on the registry; 18 are open to participants now.

Of its 104 completed or terminated interventional studies of FDA-regulated products, 69 (66%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    SEP-380135 + Quinidine Gluconate

    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.

    Drug: SEP-380135 · Drug: Quinidine Gluconate

Interventions

  • DrugSEP-380135

    Oral capsules.

  • DrugQuinidine Gluconate

    Oral extended-release (ER) tablets.

06

What researchers measure

Primary outcomes

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

    Time frame: Up to Day 11

  2. 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

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

    Time frame: Up to Day 11

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

    Time frame: Up to Day 11

Secondary outcomes

  1. Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    Time frame: Up to 2 months

  2. Number of Participants With Potentially Clinically Significant Changes in Vital Signs

    Time frame: Up to 2 months

  3. Number of Participants With Potentially Clinically Significant Changes in Electrocardiogram (ECG) Parameters

    Time frame: Up to 2 months

  4. Number of Participants With Potentially Clinically Significant Changes in Physical Examinations

    Time frame: Up to 2 months

  5. Number of Participants With Potentially Clinically Significant Changes in Neurological Examinations

    Time frame: Up to 2 months

  6. Number of Participants With Potentially Clinically Significant Changes in Clinical Laboratory Test Parameters

    Time frame: Up to 2 months

  7. 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

07

Study locations

1 site
  • Dr. Vince Clinical Research
    Overland Park, Kansas 66212, United States
08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07305779
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Responsible party
Sponsor
First posted
Dec 26, 2025
Start date
Mar 7, 2025
Primary completion
May 3, 2025
Completion
May 3, 2025
Last update
Jan 15, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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