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Enrolling by invitation Phase 2

An Open-Label Extension Study to Evaluate the Safety and Tolerability of SPT-300 (GlyphAllo) in Participants With Major Depressive Disorder, With or Without Anxious Distress (BUOY-1 OLE Study)

NCT07161700 · tracked via the Priya Life Science Poland tracker
Sponsor
Seaport Therapeutics
Phase
Phase 2
Started
2025-09-02
Last updated
2026-10-06

Condition(s) studied

Major Depressive Disorder (MDD)Major Depressive Disorder With Anxious Distress

Investigational drug(s) / intervention(s)

SPT-300 →

SPT-300: A prodrug of allopregnanolone, a small molecule drug

Study summary

This is an open-label, monotherapy, extension study to evaluate the safety and tolerability of SPT-300 (GlyphAllo) in adults with major depressive disorder (MDD), with or without anxious distress.

Eligibility

Sex
ALL
Min age
18 Years
Max age
66 Years
Healthy volunteers
No
Inclusion Criteria: * Participant who completed treatment in Study SPT-300-2024-203 (i.e., participant who competed Visit 8 \[Day 42\] of Study SPT-300-2024-203 \[BUOY-1 Study\]). * Women of childbearing potential (WOCP) must not plan to become pregnant during the course of the study or be currently breastfeeding. WOCP must agree to use a highly effective form of contraception during participation in the study and for 30 days after receiving the last dose of study treatment. * Participant is willing and able to refrain from the use of drugs of abuse. Exclusion Criteria: * Participants who, in the opinion of the Investigator, medical monitor, or Sponsor, should not participate in the study. * Participants who, in the judgment of the Investigator, were noncompliant with trial procedures or with study treatment administration during the double-blind study (BUOY-1 Study). * Female participants with a positive urine pregnancy test result. Female participants may be enrolled without a negative urine test if they are surgically sterile or at least 2 years post-menopause.

Primary outcome measure(s)

  • Safety and tolerability assessments based on Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and validated clinical scales and procedures — Up to Day 49
    Adverse events (AEs) are monitored from Day 1 to 49. A TEAE is as any AE with an onset after first dose of study treatment up to Day 49. Clinically significant abnormalities in clinical laboratory evaluations, ECGs, vital signs, physical examinations and Columbia Suicide Severity Rating Scale (C-SSRS) will be reported as TEAEs.

Trial sites (42)

FacilityCityRegionStatus
Seaport Investigator Site Chino California
Seaport Investigator Site Garden Grove California
Seaport Investigator Site Glendale California
Seaport Investigator Site San Jose California
Seaport Investigator Site Cromwell Connecticut
Seaport Investigator Site Lauderhill Florida
Seaport Investigator Site Palm Bay Florida
Seaport Investigator Site West Palm Beach Florida
Seaport Investigator Site Atlanta Georgia
Seaport Investigator Site Decatur Georgia
Seaport Investigator Site Boston Massachusetts
Seaport Investigator Site St Louis Missouri
Seaport Investigator Site Brooklyn New York
Seaport Investigator Site Cedarhurst New York
Seaport Investigator Site New York New York
Seaport Investigator Site Staten Island New York
Seaport Investigator Site Independence Ohio
Seaport Investigator Site North Canton Ohio
Seaport Investigator Site Irving Texas
Seaport Investigator Site Richardson Texas
Seaport Investigator Site Plovdiv Bulgaria
Seaport Investigator Site Sofia Bulgaria
Seaport Investigator Site Brno Czechia
Seaport Investigator Site Prague Czechia
Seaport Investigator Site Prague Czechia
Seaport Investigator Site Prague Czechia
Seaport Investigator Site Prague Czechia
Seaport Investigator Site Berlin Brandenburg
Seaport Investigator Site Schwerin Mecklenburg-Vorpommern
Seaport Investigator Site Bad Homburg Germany
Seaport Investigator Site Chemnitz Germany
Seaport Investigator Site Budapest Hungary
Seaport Investigator Site Budapest Hungary
Seaport Investigator Site Bialystok Poland
Seaport Investigator Site Bialystok Poland
Seaport Investigator Site Bydgoszcz Poland
Seaport Investigator Site Gdansk Poland
Seaport Investigator Site Leszno Poland
Seaport Investigator Site Poznan Poland
Seaport Investigator Site Tuszyn Poland

+ 2 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07161700 on ClinicalTrials.gov ↗ ← All trials in Poland