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

Completed · Phase 1

Conditions studied: Schizophrenia

In brief

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.

Key facts

Study ID

NCT07305779

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

12

Starts

2025-03-07

Expected to finish

2025-05-03

Last updated by the study team

2026-01-15

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Dr. Vince Clinical Research — Overland Park, Kansas, United States

Full record on ClinicalTrials.gov

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