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

Part of paid clinical trials in Los Alamitos, California.

Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study ID
NCT07549581
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • SEP-380135 — DRUG
    oral capsule.
  • Placebo — DRUG
    Placebo capsule.

Study Details

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).

Key Dates

Start date
Nov 7, 2024
Status verified
Apr 2026
Primary completion
Sep 12, 2025
Completion
Sep 12, 2025

Study Design

Enrollment
43 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    Participants receive SEP-380135 Dose Level 1, orally once daily (QD) from Day 1 to Day 14.
  • Experimental: Cohort 2
    Participants receive SEP-380135 Dose Level 2 orally once daily (QD) from Day 1 through Day 14.
  • Experimental: Cohort 3
    Participants receive SEP-380135 Dose Level 3 orally once daily (QD) from Day 1 through Day 14.
  • Experimental: Cohort 4
    Participants receive SEP-380135 Dose Level 4 orally once daily (QD) from Day 1 through Day 14.
  • Placebo Comparator: Placebo
    Participants receive SEP-380135 matching-placebo orally orally once daily (QD) from Day 1 to Day 14.

Primary Outcome Measure

All Cohorts: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Treatment Emergent Adverse Events (TEAEs) Leading to Trial Discontinuation [ Time Frame: Up to Day 44 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Collaborative Neuroscience Research, LLCLos AlamitosCalifornia90720-

Find similar trials in Los Alamitos, CA

By condition
Bipolar disorderSchizophrenia
By specialty
PsychiatryMental healthBehavioral health
By research site
Collaborative Neuroscience Research, LLC· Los Alamitos, CA

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