A Study of SEP-380135 in Adults With Schizophrenia or Major Depressive Episode

Otsuka

Status and phase: Completed; Phase 1

Conditions: Schizophrenia; Bipolar Disorder; Major Depressive Disorder (MDD)

Treatments: Drug: Placebo; Drug: SEP-380135

Study type: Interventional

Funder types: Industry

Identifiers

NCT07549581

384-201-00002

Details and patient eligibility

About

The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple dose oral administration of SEP-380135 in participants with schizophrenia or with a major depressive episode associated with bipolar I or II disorder or major depressive disorder (MDD).

Enrollment: 43 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• BMI from 18.0 to 35.0 kilograms per square meter (kg/m^2) (inclusive).
• Participants with a primary diagnosis of schizophrenia (cohorts 1 to 3) or bipolar I or II disorder or MDD (cohort 4) for at least 1 year (at screening), as established by clinical review, using the DSM-5 as a reference, and confirmed using the Mini international neuropsychiatric interview (MINI).
• For cohorts 1 to 3: deemed to have residual symptoms of schizophrenia at screening (i.e., be at least "mildly ill" per CGI-S criteria [CGI-S greater than or equal to (≥) 3]) and a PANSS criteria of less than or equal to (≤) 75. For cohort 4 only: deemed to be currently experiencing an MDE. Participants must be at least "moderately ill" per CGI-S criteria (CGI-S ≥ 4).
• Ability to provide written, informed consent prior to initiation of any trial-related procedures, and ability, in the opinion of the PI, to comply with all the requirements of the trial.

Exclusion criteria

• Attempted suicide within 12 months prior to screening
• A disorder or history of a condition, or previous gastrointestinal conditions that may interfere with drug absorption, distribution, metabolism, excretion, gastrointestinal motility, or pH, or a history of clinically significant abnormality of the hepatic (including participants with moderate [Child-Pugh Class B] and severe [Child-Pugh Class C] hepatic impairment) or renal system (a glomerular filtration rate less than (<) 60 milliliters per minute (mL/min)), or a history of malabsorption, bowel resection, bariatric surgery or gastric band/lap band surgery, or is on medications that might interfere with gastric motility.
• Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or bilirubin ≥ 2 times the upper limit of the reference ranges provided by the safety laboratory at screening, or total bilirubin ≥ 2 times the upper limit of reference (except for participants with Gilbert's syndrome or similar condition).
• Has any clinically significant unstable medical condition, clinically significant chronic disease, or any psychiatric symptom or diagnosis that in the opinion of the investigator, MM, or sponsor would pose a risk to the participant or the scientific objectives of the trial.

Note: Other protocol-specified Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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43 participants in 5 patient groups, including a placebo group

Cohort 1

Experimental group

Description:

Participants receive SEP-380135 Dose Level 1, orally once daily (QD) from Day 1 to Day 14.

Treatment:

Drug: SEP-380135

Cohort 2

Experimental group

Description:

Participants receive SEP-380135 Dose Level 2 orally once daily (QD) from Day 1 through Day 14.

Treatment:

Drug: SEP-380135

Cohort 3

Experimental group

Description:

Participants receive SEP-380135 Dose Level 3 orally once daily (QD) from Day 1 through Day 14.

Treatment:

Drug: SEP-380135

Cohort 4

Experimental group

Description:

Participants receive SEP-380135 Dose Level 4 orally once daily (QD) from Day 1 through Day 14.

Treatment:

Drug: SEP-380135

Placebo

Placebo Comparator group

Description:

Participants receive SEP-380135 matching-placebo orally orally once daily (QD) from Day 1 to Day 14.

Treatment:

Drug: Placebo