Recruiting

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

Study Aim

This 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

Behavior

+ Fasting

+ Feeding Behavior

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 SponsorSyndeio Biosciences, Inc

Study ContactRonald M Burch, MD, PhDMore contacts

Last updated: December 19, 2025

Sourced from a government-validated database.Claim as a partner

Study start date: July 24, 2025

Actual 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

NCT07099989

Principal SponsorSyndeio Biosciences, Inc

Study ContactRonald M Burch, MD, PhDMore contacts

Last updated: December 19, 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 enrolled

Total 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.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 59 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorFastingFeeding Behavior

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

Poor venous access

Unable to abstain from alcohol for 48 hours before admission to the clinical research until discharge

Contraindications to lumbar puncture for CSF collection:

Suspicion of increased intracranial pressure due to a mass in the brain

Show More Criteria

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

Secondary Objectives

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 Research

Overland Park, United StatesSee the location

Recruiting

One Study Center