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Pharmacokinetics Study of GATE-251 in Fasted and Fed Conditions in Healthy Adults

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
Study AimThis study observes how GATE-251 behaves in your body when you take it fasted or fed as a healthy adult, looking at the maximum concentration and area under the curve in both plasma and cerebrospinal fluid.
What is being tested

Zelquistinel 3 mg

+ Zelquistinel 10 mg
Drug
Who is being recruted

Healthy Volunteers in Fed and Fasted State

From 18 to 59 Years
+46 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: July 2025

See protocol details

Summary

Principal SponsorGate Neurosciences, Inc
Study ContactRonald M Burch, MD, PhD
Last updated: August 1, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: July 24, 2025Actual date on which the first participant was enrolled.

This clinical study is designed to understand how food affects the way the body processes a medication called GATE-251 (Zelquistinel) in healthy adults. The study involves two groups of participants, each testing a different dose of the drug, 3 mg and 10 mg. Participants take the medication in two different conditions: after fasting and after eating a high-fat, high-calorie meal. The goal is to see how these conditions influence the drug's behavior in the body, which can help determine the best way to administer the medication in the future. Participants in the study take a single dose of GATE-251 as a tablet by mouth, either after fasting overnight or after consuming a special meal. Blood, urine, and cerebrospinal fluid samples are collected at various times to measure how the drug is absorbed, distributed, and eliminated from the body. Safety is closely monitored by tracking any side effects, changes in vital signs, and other health assessments. There is a one-week break between the two testing periods when participants switch the conditions under which they take the medication. This careful monitoring helps ensure the study is safe and provides valuable data on how food impacts the drug's effectiveness.

Official TitleA Randomized, Open-Label, 2-Cohort, 2-Period Crossover Study to Evaluate the Pharmacokinetics of GATE-251 (Zelquistinel), 3 and 10 mg, Under Both Fasted and Fed Conditions in Healthy Adult Participants 
Principal SponsorGate Neurosciences, Inc
Study ContactRonald M Burch, MD, PhD
Last updated: August 1, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
32 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 59 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Healthy Volunteers in Fed and Fasted State
Criteria
14 inclusion criteria required to participate
Available for the entire study period; willing and able to comply with the protocol requirements and study restrictions, to remain at the CRU for the required duration of the study, and to return for the Follow-Up Visit
Male or female participants ≥18 to ≤59 years of age at Screening
Minimum body weight of at least 50.0 kg at Screening
Body mass index (BMI) 18.0 to 35.0 kg/m2, inclusive, at Screening

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32 exclusion criteria prevent from participating
Female participant who is currently pregnant or lactating or is planning to become pregnant during the study
Positive pregnancy test at Screening or on Day -1
Positive test results for HIV 1/2 Ag/Ab, hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) at Screening
Positive urine screen for drugs or alcohol at Screening or on Day -1

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
4 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Active Comparator
Subjects will be randomized to one of two sequences. Subjects will be dosed with GATE-251, 3 mg oral tablet, during each sequence. Each subject will serve as their own control.
Group II
Active Comparator
Subjects will be randomized to one of two sequences. Subjects will be dosed with GATE-251, 3 mg oral tablet, during each sequence. Each subject will serve as their own control.
Group III
Active Comparator
Subjects will be randomized to one of two sequences. Subjects will be dosed with GATE-251, 10 mg oral tablet, during each sequence. Each subject will serve as their own control.
Group IV
Active Comparator
Subjects will be randomized to one of two sequences. Subjects will be dosed with GATE-251, 10 mg oral tablet, during each sequence. Each subject will serve as their own control.
Study Objectives
Primary Objectives

Maximum concentration in plasma

Area under the curve from time 0 to hour 24

Maximum concentration in cerebrospinal fluid in plasma

Area under the curve from time 0 to hour 24 in cerebrospinal fluid
Secondary Objectives

Time of maximum concentration in plasma

Elimination half life in plasma

Time of maximum concentration in cerebrospinal fluid

Ellimination half life in cerebrospinal fluid

Evaluation of pulse rate

The C-SSRS assesses intensity of suicidal ideation with categories of increasing seriousness from Wish to be Dead (score 1), to Active Suicidal Ideation with Plan and Intent (score 5). The C-SSRS will be used to assess suicidal ideation and behaviors in participants who are able to complete the assessment.

Evaluation of changes in psychotic ideation in the areas of conceptual disorganization, suspiciousness, hallucinatory behavior, and unusual thought content, each of which is scored from 1 (normal) to 4 (severe) with increasing intensity for a total score from 4 to 16.

Evaluation of changes in dissociative symptoms in 23 areas, each of which is scored from 0 - not present to 4 - severe, for a total score from 0 to 92.

Evaluation of side effects experienced by subjects after drug treatment has begun

Change in systolic blood pressure

Change in diastolic blood pressure

Change in body temperature

Change in electrocardiogram QT interval

Change in electrocardiogram PR interval

Change in electrocardiogram QRS interval

Change in EEG alpha power

Change in estimated glomerular filtration rate

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Recruiting
Dr. Vince Clinical ResearchOverland Park, United StatesSee the location
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One Study Center