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

Otsuka

Status and phase: Completed; Phase 1

Conditions: Schizophrenia

Treatments: Drug: Quinidine Gluconate; Drug: SEP-380135

Study type: Interventional

Funder types: Industry

Identifiers

NCT07305779

384-201-00004

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

12 participants in 1 patient group

SEP-380135 + Quinidine Gluconate

Experimental group

Description:

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.

Treatment:

Drug: SEP-380135

Drug: Quinidine Gluconate