Suspended

GATE-251Pharmacokinetics 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

Last updated: March 21, 2026

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 study focuses on a drug called Zelquistinel, specifically its tablet form, GATE-251. The main goal is to understand how this drug behaves in the body when taken with or without food. This is important because food can affect how a drug is absorbed and works in the body. The study involves healthy adults, with about 32 participants, who will be divided into two groups. Each group will receive a different dose of Zelquistinel, either 3 mg or 10 mg, to evaluate its safety and effectiveness at these levels. During the study, participants will be given Zelquistinel under both fasted and fed conditions. For the fasted condition, the drug will be taken after an overnight fast of at least 10 hours. For the fed condition, participants will eat a high-fat, high-calorie meal about 30 minutes before taking the drug. Blood, urine, and cerebrospinal fluid samples will be collected at various times for analysis. Safety assessments, including monitoring for any adverse events, will be conducted throughout the study. The study will last for about 15 days, with a 7-day break between doses. The results will help researchers understand how food affects the body's response to Zelquistinel.

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

Last updated: March 21, 2026

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

Female participants of childbearing potential must use an acceptable method of contraception, including hormonal contraceptives, abstinence from heterosexual intercourse, intrauterine device with or without hormones, or double-barrier method (eg, condom and spermicide) for 30 days before Screening, during the study, and for 30 days after the last administration of study drug

Considered generally healthy in the opinion of an investigator upon completion of medical history, physical examination, vital sign measurements, Screening clinical laboratory test results, and Screening ECG

Able to speak, read, and understand English sufficiently to allow completion of all study assessments

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

Show More Criteria

32 exclusion criteria prevent from participating

Positive pregnancy test at Screening or on Day -1

Poor venous access

Current or history of alcohol or substance abuse, with the exception of being fully recovered with no use of alcohol or substances of abuse within the 12 months before Screening

Allergy to NMDA receptor drugs, to any component of the dosage form, or any other allergy, which, in the opinion of an investigator, contraindicates their participation

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

Suspended

Dr. Vince Clinical Research

Overland Park, United StatesOpen Dr. Vince Clinical Research in Google Maps

SuspendedOne Study Center