Healthy Volunteers in Fed and Fasted StatePhase 1GATE-251NCT07099989
Pharmacokinetics of Zelquistinel in Fasted or Fed State
A Phase 1 study testing Zelquistinel 3 mg and Zelquistinel 10 mg in people with Healthy Volunteers in Fed and Fasted State, run by Syndeio Biosciences, Inc at 1 site in United States.
Trial summary
The primary purpose of this study is to assess the effect of food on the rate and extent of absorption of a single dose of Zelquistinel 3 mg or 10 mg oral tablets tablets in healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers in Fed and Fasted State
- What is being tested?
- Zelquistinel 3 mg and Zelquistinel 10 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jul 2025to Jul 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
- Able and willing to swallow whole tablets without breaking, cutting, or chewing
- Non- or ex-smokers
Show all 14Show fewer
- 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
- 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
- Female participants of nonchildbearing potential should be surgically sterile (ie, have undergone complete hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or tubal ligation/occlusion) or in a menopausal state (at least 1 year without menses)
- Male participants must agree to use a double-barrier method (condom and spermicide) or remain abstinent from heterosexual intercourse at the time of Screening, during the study, and for 90 days after the last administration of study drug
- Male participants must agree not to donate sperm during the study and for 90 days after the last administration of study drug
- Able to fully consume the required fed meal within 30 minutes without substitutions
- Willing and able to provide written informed consent to participate in the study, is able to understand the procedures and study requirements, and agrees to comply with all required study requests and procedures
- Able to speak, read, and understand English sufficiently to allow completion of all study assessments
Who cannot join
- 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
- Clinically significant history or evidence of gastrointestinal (excluding cholecystectomy), hepatic, renal, endocrine, pulmonary, neurologic, psychiatric, cardiovascular, hematologic, dermatologic, immunologic, or metabolic disease; or any other condition or organ system disease known to interfere with the absorption, distribution, metabolism, or elimination of drugs that in the opinion of an investigator would jeopardize the safety of the participant or impact validity of study results.
- 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
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- Any clinically significant illness in the previous 30 days before Screening or Day -1
- Malignancy, a history of malignancy, or has received treatment for a malignancy at any time, with the exception of resected and cured basal cell carcinoma and squamous cell carcinoma of the skin (>1 year)
- Poor venous access
- Any medical condition(s) considered by an investigator to be clinically significant for study participation
- Supine pulse rate <60 or ≥100 bpm at Screening or on Day -1
- Donation or significant loss of blood products of 500 mL or more within 56 days before Screening, or donation or loss of plasma within 7 days before Screening
- Suicidal behavior or suicidal ideation of score 4 (active suicidal ideation with some intent to act without specific plan) or score 5 (active suicidal ideation with specific plan and intent) based on the C-SSRS within 12 months before Screening; a history of suicide attempt in the last 6 months; or more than 1 lifetime suicide attempt
- Positive responses on the CADSS or BPRS+ assessments at Screening, indicating evidence of dissociative symptoms or psychosis, as determined by the investigator
- Unable to abstain from consumption of grapefruit or Seville oranges or their juices from 14 days before the first administration of study drug until collection of the final PK sample
- Unable to abstain from caffeine- or xanthine-containing products (eg, coffee, tea, cola drinks, and chocolate) for 24 hours before admission to the clinical research unit until discharge
- Unable to abstain from alcohol for 48 hours before admission to the clinical research until discharge
- Unable to abstain from strenuous exercise for 48 hours before admission to the clincal research unit until after the collection of the final PK sample
- A marked prolongation of QT/corrected QT interval (QTc), defined as repeated QTc
- >450 ms for male participants and >470 ms for female participants using QT interval corrected for heart rate using Fridericia's formula (QTcF), at Screening or on Day -1
- Presence of observed abnormality (evidenced from physical examination, ECG [PR interval >220 ms, QRS >110 ms QRS or T wave morphology that in an investigator's opinion renders QT interval assessment unreliable], vital sign measurements, or clinical laboratory test results) considered by an investigator to be clinically significant for study participation. Out-of-range values can be repeated to confirm if the abnormality is sustained
- Use of any prescription medication (including oral contraceptives) within 14 days before Screening and/or use of any over-the-counter medications (such as antacids, vitamins, minerals, dietary/herbal preparations, and nutritional supplements) within 7 days 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
- Treatment with any investigational drug within 30 days or 5 half-lives of the drug (whichever is longer) before Screening
- Contraindications to lumbar puncture for CSF collection:
- Skin infection near the site of the lumbar puncture
- Significant scarring near the site (tattoos are acceptable)
- Uncorrected bleeding disorders
- Acute spinal cord trauma
- Suspicion of increased intracranial pressure due to a mass in the brain
- Significant degenerative changes or scoliosis of the lumbar spine
- Any reason that, in the opinion of the investigator, would prevent participation in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Dr. Vince Clinical Research
Overland Park, Kansas, 66212
About this study
Official title: A 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
The primary purpose of this study is to assess the effect of food on the rate and extent of absorption of a single dose of Zelquistinel 3 mg or 10 mg oral tablets tablets in healthy adult volunteers.
Read the detailed description
This is a randomized, open-label, single-dose, 2-cohort, 2-period crossover study to assess the effect of food on the pharmacokinetics, safety, and tolerability of zelquistinel tablet in healthy adult participants. Two dose levels, 3 and 10 mg, will each be evaluated for food effect, 1 dose level per cohort, with approximately 32 participants (16 per cohort).
- Cohort 1: zelquistinel, 3 mg single oral tablet administered under fasted and fed conditions
- Cohort 2: zelquistinel, 10 mg single oral tablet administered under fasted and fed conditions
Study Design: This is a randomized, open-label, single-dose, 2-cohort, 2-period crossover study to assess the effect of food on the pharmacokinetics, safety, and tolerability of GATE-251 tablet in healthy adult participants. Two dose levels, 3 and 10 mg, will each be evaluated for food effect, 1 dose level per cohort, with approximately 32 participants (16 per cohort).
- Cohort 1: zelquistinel, 3 mg single oral tablet administered under fasted and fed conditions
- Cohort 2: zelquistinel, 10 mg single oral tablet administered under fasted and fed conditions After meeting eligibility requirements, participants will be admitted to the clinical research unit on Day -1. Participants within each cohort will be randomly assigned in a 1:1 ratio to a treatment sequence. Cohorts will be enrolled sequentially. Participants will only participate in 1 cohort.
On Day 1 of each period, participants will receive one of the following treatments:
- Treatment A (reference): zelquistinel, 3 mg tablet, fasted conditions
- Treatment B (test): GATE-251, 3 mg tablet, fed conditions (high-fat, high-calorie meal)
- Treatment C (reference): zelquistinel, 10 mg tablet, fasted conditions
- Treatment D (test): zelquistinel, 10 mg tablet, fed conditions (high-fat, high-calorie meal) Fasted and fed conditions and test meal composition are defined by FDA guidance. For the fasted condition, zelquistinel will be administered after an overnight fast of at least 10 hours.
For the fed condition, after an overnight fast of at least 10 hours, participants will start the test meal approximately 30 minutes before administration of zelquistinel. The test meal will be entirely consumed within 30 minutes.
For both fasted and fed conditions, zelquistinel will be administered with approximately 240 mL of water. Up to 200 mL of additional water will be allowed in increments of 50 mL, as needed. No water will be allowed for at least 1 hour before or after zelquistinel administration, except for the water consumed during administration. No food will be allowed for at least 4 hours after zelquistinel administration. In addition, participants will be semi-recumbent during the test meal and for at least 4 hours after study drug administration, except for when procedures or adverse events require the supine position.
The test meal will be a standard high-fat, high-calorie meal consisting of approximately 1000 calories with approximately 50% of the total calories from fat.
There will be a 7-day washout interval between doses then participants will cross over to Period 2 and receive zelquistinel at the same dose as in Period 1 under the alternate fasted or fed condition. Participants will be confined to the clinical study unit from Study Day -1 through Study Day 10 and will return on approximately Study Day 15 (7±2 days from the last dose) for the Follow-Up Visit (end of study).
Samples will be collected for pharmacokinetic analysis at the following timepoints for plasma, urine, and CSF.
- Plasma: On Day 1 of each period, blood samples will be collected at: 0 (pre-dose) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours after dosing.
- Urine: On Day 1 of each period, urine samples will be collected at: 0 (pre-dose) and 0-4-, 4-8-, 8-12-, and 12-24-hour intervals after dosing.
- Cerebrospinal fluid (CSF) collection: On Day 1 of each period, CSF samples will be collected at: 0 (pre-dose) and 1, 2, 4, 8, 12, 16, and 24 hours after dosing.
Safety assessments will include reporting of adverse events; clinical laboratory test results; vital sign measurements; electrocardiogram (ECG) results; and Columbia Suidical Severity Rating Scale (C-SSRS), Brief Psychiatric Rating Scale Positive Symptoms (BPRS+), and Clinician Administered Dissociative States Scale (CADSS) results. Adverse events, including serious adverse events (SAEs) and adverse events of special interest (AESIs), will be recorded from the time of informed consent until study completion.
- Being tested
- Zelquistinel 3 mg, Zelquistinel 10 mg
- Keywords
- GATE-251, zelquistinel, N-methyl-D-aspartate (NMDA) receptor positive allosteric modulator, pharmacokinetics
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zelquistinel 3 mgDrug
Subjects will receive Zelquistinel 3 mg in fed and fasted state (high fat meal).
Zelquistinel 10 mgDrug
Subjects will receive Zelquistinel 10 mg in fed and fasted state (high fat meal).
| Study group | Role | What they receive |
|---|---|---|
| Zelquistinel, 3 mg Fasted | 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. Receives: Drug: Zelquistinel 3 mg |
| Zelquistinel, 3 mg Fed | 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. Receives: Drug: Zelquistinel 3 mg |
| Zelquisitinel, 10 mg Fasted | 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. Receives: Drug: Zelquistinel 10 mg |
| Zelquistinel, 10 Fed | 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. Receives: Drug: Zelquistinel 10 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameter Maximum Concentration (Cmax) in plasma
Maximum concentration in plasma
Measured: Hour zero to Hour 24
Pharmacokinetic parameter Area Under the Curve (AUC) for Concentration in plasma over time
Area under the curve from time 0 to hour 24
Measured: Hour 0 to hour 24
Pharmacokinetic parameter Maximum Concentration (Cmax) in cerebrospinal fluid
Maximum concentration in cerebrospinal fluid in plasma
Measured: Hour 0 to Hour 24
Pharmacokinetic parameter Area Under the Curve (AUC) for concentration in cerebrospinal fluid over time
Area under the curve from time 0 to hour 24 in cerebrospinal fluid
Measured: Hour 0 to hour 24
Secondary outcomes (17)
Pharmacokinetic parameter Time of Maximum Concentration (Tmax) in plasma
Time of maximum concentration in plasma
Measured: Hour 0 to hour 24
Pharmacokinetic parameter Elimination Half-Life (T1/2) in plasma
Elimination half life in plasma
Measured: Hour 0 to hour 24
Pharmacokinetic parameter maximum concentration (Tmax) in cerebrospinal fluid
Time of maximum concentration in cerebrospinal fluid
Measured: Hour 0 to hour 24
Pharmacokinetic parameter Elimination Half-Life (T1/2) in cerebrospinal fluid
Ellimination half life in cerebrospinal fluid
Measured: Hour 0 to hour 24
Safety - Pulse Rate
Evaluation of pulse rate
Measured: Day -1 to Day 10
Safety - Columbia Suicide Severity Rating Scale (C-SSRS)
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.
Measured: Day -1 to day 10
Safety - Brief Psychiatric Rating Scale, positive symptoms (BPRS+)
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.
Measured: Day -1 to Day 10
Safety - Clinician-Administered Dissociative States Scale (CADSS)
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.
Measured: Day -1 to Day 10
Safety - Treatment Emergent Adverse Events (TEAE) reported by subjects after treatment has begun
Evaluation of side effects experienced by subjects after drug treatment has begun
Measured: Day -1 to Day 10
Safety Systolic Blood Pressure
Change in systolic blood pressure
Measured: Day -1 to Day 10
Safety Diastolic Blood Pressure
Change in diastolic blood pressure
Measured: Day -1 to Day 10
Safety Body Temperature
Change in body temperature
Measured: Day -1 to Day 10
Safety Electrocardiogram QT Interval
Change in electrocardiogram QT interval
Measured: Day -1 to Day 10
Safety Electrocardiogram PR Interval
Change in electrocardiogram PR interval
Measured: Day -1 to Day 10
Safety Electrocardiogram QRS Interval
Change in electrocardiogram QRS interval
Measured: Day -1 to Day 10
Pharmacodynamics EEG alpha power
Change in EEG alpha power
Measured: Day -1 to Day 10
Safety estimated Glomerular Filtration Rate (eGFR)
Change in estimated glomerular filtration rate
Measured: Day -1 to Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start24 Jul 2025
- Primary completion5 Feb 2026
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteers in Fed and Fasted StateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Syndeio Biosciences, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dr. Vince Clinical Research
- Responsible party
- Sponsor
- Investigators
- Ronald Burch Burch, MD, PhD, Study director, Syndeio Biosciences, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07099989
- Sponsor's protocol ID
- GATE-251-C-110
- Acronym
- GATE-251
- Status last verified
- Mar 2026
- First submitted
- 21 Jul 2025
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 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
- ClinicalTrials.gov ID
- NCT07099989
- Acronym / sponsor ID
- GATE-251 / GATE-251-C-110
- Keywords
- GATE-251, zelquistinel, N-methyl-D-aspartate (NMDA) receptor positive allosteric modulator, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Syndeio Biosciences, IncIndustry (pharma, biotech, devices)
- Collaborators
- Dr. Vince Clinical Research
- Study start
- 24 Jul 2025 (actual)
- Primary completion
- 5 Feb 2026 (actual)
- Study completion
- Jul 2026 (estimated)
- First posted
- 1 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to assess the effect of food on the rate and extent of absorption of a single dose of Zelquistinel 3 mg or 10 mg oral tablets tablets in healthy adult volunteers.
Detailed description
This is a randomized, open-label, single-dose, 2-cohort, 2-period crossover study to assess the effect of food on the pharmacokinetics, safety, and tolerability of zelquistinel tablet in healthy adult participants. Two dose levels, 3 and 10 mg, will each be evaluated for food effect, 1 dose level per cohort, with approximately 32 participants (16 per cohort).
- Cohort 1: zelquistinel, 3 mg single oral tablet administered under fasted and fed conditions
- Cohort 2: zelquistinel, 10 mg single oral tablet administered under fasted and fed conditions
Study Design: This is a randomized, open-label, single-dose, 2-cohort, 2-period crossover study to assess the effect of food on the pharmacokinetics, safety, and tolerability of GATE-251 tablet in healthy adult participants. Two dose levels, 3 and 10 mg, will each be evaluated for food effect, 1 dose level per cohort, with approximately 32 participants (16 per cohort).
- Cohort 1: zelquistinel, 3 mg single oral tablet administered under fasted and fed conditions
- Cohort 2: zelquistinel, 10 mg single oral tablet administered under fasted and fed conditions After meeting eligibility requirements, participants will be admitted to the clinical research unit on Day -1. Participants within each cohort will be randomly assigned in a 1:1 ratio to a treatment sequence. Cohorts will be enrolled sequentially. Participants will only participate in 1 cohort.
On Day 1 of each period, participants will receive one of the following treatments:
- Treatment A (reference): zelquistinel, 3 mg tablet, fasted conditions
- Treatment B (test): GATE-251, 3 mg tablet, fed conditions (high-fat, high-calorie meal)
- Treatment C (reference): zelquistinel, 10 mg tablet, fasted conditions
- Treatment D (test): zelquistinel, 10 mg tablet, fed conditions (high-fat, high-calorie meal) Fasted and fed conditions and test meal composition are defined by FDA guidance. For the fasted condition, zelquistinel will be administered after an overnight fast of at least 10 hours.
For the fed condition, after an overnight fast of at least 10 hours, participants will start the test meal approximately 30 minutes before administration of zelquistinel. The test meal will be entirely consumed within 30 minutes.
For both fasted and fed conditions, zelquistinel will be administered with approximately 240 mL of water. Up to 200 mL of additional water will be allowed in increments of 50 mL, as needed. No water will be allowed for at least 1 hour before or after zelquistinel administration, except for the water consumed during administration. No food will be allowed for at least 4 hours after zelquistinel administration. In addition, participants will be semi-recumbent during the test meal and for at least 4 hours after study drug administration, except for when procedures or adverse events require the supine position.
The test meal will be a standard high-fat, high-calorie meal consisting of approximately 1000 calories with approximately 50% of the total calories from fat.
There will be a 7-day washout interval between doses then participants will cross over to Period 2 and receive zelquistinel at the same dose as in Period 1 under the alternate fasted or fed condition. Participants will be confined to the clinical study unit from Study Day -1 through Study Day 10 and will return on approximately Study Day 15 (7±2 days from the last dose) for the Follow-Up Visit (end of study).
Samples will be collected for pharmacokinetic analysis at the following timepoints for plasma, urine, and CSF.
- Plasma: On Day 1 of each period, blood samples will be collected at: 0 (pre-dose) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours after dosing.
- Urine: On Day 1 of each period, urine samples will be collected at: 0 (pre-dose) and 0-4-, 4-8-, 8-12-, and 12-24-hour intervals after dosing.
- Cerebrospinal fluid (CSF) collection: On Day 1 of each period, CSF samples will be collected at: 0 (pre-dose) and 1, 2, 4, 8, 12, 16, and 24 hours after dosing.
Safety assessments will include reporting of adverse events; clinical laboratory test results; vital sign measurements; electrocardiogram (ECG) results; and Columbia Suidical Severity Rating Scale (C-SSRS), Brief Psychiatric Rating Scale Positive Symptoms (BPRS+), and Clinician Administered Dissociative States Scale (CADSS) results. Adverse events, including serious adverse events (SAEs) and adverse events of special interest (AESIs), will be recorded from the time of informed consent until study completion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Zelquistinel, 3 mg Fasted | Active comparator | Drug: Zelquistinel 3 mgSubjects 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. |
| Zelquistinel, 3 mg Fed | Active comparator | Drug: Zelquistinel 3 mgSubjects 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. |
| Zelquisitinel, 10 mg Fasted | Active comparator | Drug: Zelquistinel 10 mgSubjects 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. |
| Zelquistinel, 10 Fed | Active comparator | Drug: Zelquistinel 10 mgSubjects 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. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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
- Able and willing to swallow whole tablets without breaking, cutting, or chewing
Key exclusion criteria (32 listed)
- 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
- Clinically significant history or evidence of gastrointestinal (excluding cholecystectomy), hepatic, renal, endocrine, pulmonary, neurologic, psychiatric, cardiovascular, hematologic, dermatologic, immunologic, or metabolic disease; or any other condition or organ system disease known to interfere with the absorption, distribution, metabolism, or elimination of drugs that in the opinion of an investigator would jeopardize the safety of the participant or impact validity of study results.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zelquistinel 3 mgSubjects will receive Zelquistinel 3 mg in fed and fasted state (high fat meal). | Drug | Zelquistinel, 3 mg Fasted, Zelquistinel, 3 mg Fed |
| Zelquistinel 10 mgSubjects will receive Zelquistinel 10 mg in fed and fasted state (high fat meal). | Drug | Zelquisitinel, 10 mg Fasted, Zelquistinel, 10 Fed |
Primary outcome
Pharmacokinetic parameter Maximum Concentration (Cmax) in plasma
Time frame: Hour zero to Hour 24
Maximum concentration in plasma
Pharmacokinetic parameter Area Under the Curve (AUC) for Concentration in plasma over time
Time frame: Hour 0 to hour 24
Area under the curve from time 0 to hour 24
Pharmacokinetic parameter Maximum Concentration (Cmax) in cerebrospinal fluid
Time frame: Hour 0 to Hour 24
Maximum concentration in cerebrospinal fluid in plasma
Pharmacokinetic parameter Area Under the Curve (AUC) for concentration in cerebrospinal fluid over time
Time frame: Hour 0 to hour 24
Area under the curve from time 0 to hour 24 in cerebrospinal fluid
17 secondary outcomes
Pharmacokinetic parameter Time of Maximum Concentration (Tmax) in plasma
Time frame: Hour 0 to hour 24
Pharmacokinetic parameter Elimination Half-Life (T1/2) in plasma
Time frame: Hour 0 to hour 24
Pharmacokinetic parameter maximum concentration (Tmax) in cerebrospinal fluid
Time frame: Hour 0 to hour 24
Pharmacokinetic parameter Elimination Half-Life (T1/2) in cerebrospinal fluid
Time frame: Hour 0 to hour 24
Safety - Pulse Rate
Time frame: Day -1 to Day 10
Safety - Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: Day -1 to day 10
Safety - Brief Psychiatric Rating Scale, positive symptoms (BPRS+)
Time frame: Day -1 to Day 10
Safety - Clinician-Administered Dissociative States Scale (CADSS)
Time frame: Day -1 to Day 10
Safety - Treatment Emergent Adverse Events (TEAE) reported by subjects after treatment has begun
Time frame: Day -1 to Day 10
Safety Systolic Blood Pressure
Time frame: Day -1 to Day 10
Safety Diastolic Blood Pressure
Time frame: Day -1 to Day 10
Safety Body Temperature
Time frame: Day -1 to Day 10
Safety Electrocardiogram QT Interval
Time frame: Day -1 to Day 10
Safety Electrocardiogram PR Interval
Time frame: Day -1 to Day 10
Safety Electrocardiogram QRS Interval
Time frame: Day -1 to Day 10
Pharmacodynamics EEG alpha power
Time frame: Day -1 to Day 10
Safety estimated Glomerular Filtration Rate (eGFR)
Time frame: Day -1 to Day 10
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald Burch Burch, MD, PhD study director
Syndeio Biosciences, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Zelquistinel 3 mg and Zelquistinel 10 mg in people with Healthy Volunteers in Fed and Fasted State, run by Syndeio Biosciences, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic parameter Maximum Concentration (Cmax) in plasma (time frame: Hour zero to Hour 24). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.