GATE-251 for Healthy Volunteers
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how food affects the absorption of a new medication, GATE-251, in healthy individuals. Participants will take either a 3 mg or 10 mg dose of the medication in various settings, such as with and without food, to observe how the body absorbs it. The trial is suitable for generally healthy individuals who do not smoke and can swallow tablets whole. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new medication.
Do I need to stop taking my current medications to join the trial?
Yes, you need to stop taking any prescription medications 14 days before the trial and any over-the-counter medications 7 days before the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that GATE-251, also known as zelquistinel, targets specific brain receptors and may reduce severe side effects often seen with similar medications. Earlier studies have focused on its safety and tolerability in healthy volunteers, identifying common and serious side effects. Although specific details about these side effects are not available, the progression of GATE-251 to clinical trials suggests that initial safety results are promising enough to warrant further study. It is important to remember that joining early trials carries risks, as complete safety information is still being gathered.12345
Why are researchers excited about this trial's treatment?
Researchers are excited about GATE-251, also known as Zelquistinel, because it represents a novel approach to treatment by targeting the NMDA receptors in the brain, which play a key role in mood regulation. Unlike standard antidepressants that often take weeks to show effects, Zelquistinel has the potential to act much faster, offering quicker relief for patients. Additionally, GATE-251 comes in both 3 mg and 10 mg oral tablets, with variations for fasted and fed states, potentially providing flexibility in dosing and better patient adherence. These unique features could lead to more efficient management of mood disorders, sparking interest in its further development.
What evidence suggests that this trial's treatments could be effective?
Research has shown that GATE-251, also known as zelquistinel, may help treat depression. It works by positively affecting certain parts of the brain, improving mood and mental health. Studies suggest that zelquistinel can quickly and effectively reduce symptoms of depression, with lasting effects. This potential breakthrough offers hope for people with depression. Although more clinical data is needed, early results are promising for its effectiveness.14678
Who Is on the Research Team?
Ronald Burch Burch, MD, PhD
Principal Investigator
Syndeio Biosciences, Inc
Are You a Good Fit for This Trial?
This trial is for healthy adults who can either eat normally or follow an intermittent fasting schedule. Specific details about who can join are not provided, but typically participants must meet certain health standards and not be taking conflicting medications.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Period 1
Participants receive a single dose of GATE-251 under either fasted or fed conditions
Washout
A 7-day washout interval between doses
Treatment Period 2
Participants receive a single dose of GATE-251 under the alternate condition (fasted or fed)
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- GATE-251
Find a Clinic Near You
Who Is Running the Clinical Trial?
Syndeio Biosciences, Inc
Lead Sponsor
Dr. Vince Clinical Research
Collaborator