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Completed

NCT Number: NCT07305779

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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Dr. Vince Clinical Research

Overland Park, Kansas, 66212, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • 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.

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.
  • 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.

Treatment and study plan

SEP-380135

Drug

Oral capsules.

Quinidine Gluconate

Drug

Oral extended-release (ER) tablets.

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

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 26, 2025
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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