A Phase 1, Single-Center, Double-Blind, Randomized, Placebo-Controlled Study to Explore the Effect of SP-624 on Brain Network Analytics in Cohorts of Healthy Adult Subjects and Subjects With Major Depressive Disorder

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

The main goal of this clinical trial is to learn if the active study drug (code name: SP-624) has any effect on the electrical activity of the brain in adult healthy volunteers and in adults with major depression. Another goal of the study is to learn if SP-624 improves memory and learning in adults with major depression. The study will also provide additional information on the safety of SP-624 and how well it is tolerated in adult healthy volunteers and adults with major depression. Researchers will compare SP-624 to a placebo (a look-alike substance that contains no drug) to see if SP-624 has any effect on study tests. Study participants will: Take capsules of study drug (SP-624 or a placebo) once daily for 2 weeks; visit the clinic at Screening, Day 1 (first dose of study drug), and Day 15 (last dose of study drug) for checkups and tests; and have phone call check-ups on Day 7 and about 1 week after the last dose of study drug.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: t
View:

• In generally good health

• Body mass index (BMI) between 18.0 and 40.0 kg/m2

• Willing to comply with the requirements of the study

• For participants with depression: must meet study criteria for moderate to severe major depressive disorder

Locations
United States
California
CenExel CNS
RECRUITING
Garden Grove
Nebraska
Alivation Research
COMPLETED
Lincoln
Time Frame
Start Date: 2024-08-22
Estimated Completion Date: 2025-12
Participants
Target number of participants: 36
Treatments
Experimental: SP-624
SP-624 oral capsule, once daily for 2 weeks
Placebo_comparator: Placebo
Placebo oral capsule, once daily for 2 weeks
Related Therapeutic Areas
Sponsors
Leads: Sirtsei Pharmaceuticals, Inc.

This content was sourced from clinicaltrials.gov