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NCT07305779CompletedPhase 1

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

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

Source: ClinicalTrials.gov · Last updated 15 Jan 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
12 (actual)
First submitted
12 Dec 2025
Start date
Mar 2025
Primary completion date
May 2025
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
NCT number
NCT07305779

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 12
  • From Mar 2025 to the primary completion date, May 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.
  • Attempted suicide within 12 months prior to screening.

Lab values

  • 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.

Other

  • Are currently participating in another clinical trial.
  • In the opinion of the investigator, should not participate in the trial.
    • Note: Other protocol-specified inclusion/exclusion criteria may apply.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 55 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Dr. Vince Clinical Research
Coordinator of this site? Confirm its status
Overland ParkUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.