Major Depressive DisorderPhase 1NCT04618263
Safety and Tolerability of Single and Multiple Ascending Doses of GATE-101 in Normal Human Volunteers
A Phase 1 study testing GATE-101 in people with Major Depressive Disorder and Excessive Sleepiness, run by Syndeio Biosciences, Inc at 1 site in United States.
Trial summary
To evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of GATE-101 in normal human volunteers Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder, Excessive Sleepiness
- What is being tested?
- GATE-101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2020to 13 Aug 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal, healthy volunteer male and female subjects
- Aged 18 to 40 years
- For female subjects must meet one of the following:
- Surgically sterile or at least 2 years menopausal, confirmed by follicle stimulating hormone (FSH) at screening visit, or,
- If of childbearing potential, subject must use an acceptable method of birth control from date of screening to at least 30 days after the last dose of study drug. Must have a documented negative blood or urine pregnancy test within 24 hours prior to dosing. If reported sterile or postmenopausal, will be confirmed by FSH.
- For male subjects, must meet one of the following:
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- Surgically sterile
- If not surgically sterile then use of an acceptable form of contraception (condom) from the time of randomization through 30 days following the last dose of study drug. Male subjects are strongly advised to inform female partners of the need for them to use highly effective birth control during this time period.
- Body mass index (BMI) < 30
- Clinical laboratory values <2 times the upper limit of normal (ULN) or deemed not clinically significant by the Investigator.
- Ability to understand the requirements of the study, provide written informed consent, abide by the study restrictions, and agree to return for the required assessments.
Who cannot join
- Human immunodeficiency virus (HIV) infection, or hepatitis or other ongoing infectious disease
- Evidence of alcohol abuse (greater than 4 units of alcohol on most days; 1 unit = 1/2 pint of beer, 1 glass of wine or 1 oz. of spirits). Alcohol consumption should be avoided for at least 24 hours prior to baseline/dosing visit. A positive alcohol breathalyzer at screening and baseline visit
- Current abuse of illicit substances, using the Diagnostic and Statistical Manual (DSM) V definition of substance use disorder.
- Current cigarette/tobacco smoker or use of other tobacco or nicotine products including ecigarettes or vaping (if formerly a smoker must not have smoked for at least one year prior to enrolling in this study). Nonsmoking will be confirmed by cotinine assay.
- Currently pregnant, planning to become pregnant during the course of the study, or nursing mother
- Impaired renal function (GFR < 90 ml/min)
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- Elevated systolic blood pressure (> 130 mmHg) or diastolic blood pressure (> 80 mmHg) and/or increased QTc (>450 msec for men or >470 msec for women) or additional risk factors for Torsades de Pointes including heart failure, hypokalemia, family history of Long QT Syndrome
- Type I or Type II diabetes
- Malignancy in the last 5 years, with the exception of nonmetastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix
- Currently taking prescription (except as listed in Section 7.4.1) or over-the-counter medications including herbal therapies, within 14 days of enrollment into the study.
- History of allergy or sensitivity, or intolerance to NMDAR ligands including ketamine, dextromethorphan, memantine, methadone, dextropropoxyphene, or ketobemidone
- Received another investigational drug or device within 30 days of enrollment in this study
- Previously participated in this study
- Psychiatric disease including major depression, bipolar disorder, anxiety, or schizophrenia, or other medical condition that, in the opinion of the Investigator, would interfere with the evaluation of study drug safety
- For subjects in lumbar catheter Groups (6 and 7) has a history of excessive bleeding after invasive procedures or surgery or known coagulation or platelet abnormality, or has been on any blood thinner or medication affecting platelet function, such as aspirin, nonsteroidal anti-inflammatory medications, corticosteroids (except topical) or warfarin within the 7 days prior to enrollment, or has known allergy to any anesthetic agent that may be used for the lumbar puncture.
- For subjects in lumbar catheter Groups (6 and 7) has a history of infection that required IV antibiotics within the 45 days or oral antibiotics within 30 days prior to enrollment, and, at the time of clinic admission, be febrile or have signs/symptoms consistent with an infection.
- For subjects in lumbar catheter Groups (6 and 7) has a history of or physical examination evidence of a lumbar spine abnormality that may preclude placement of a spinal catheter, presence of intraspinal shunt devices (e.g. ventriculoperitoneal shunt), or history of elevated intracranial pressure, normal pressure hydrocephalus, or other neurological condition that in the opinion of the Investigator precludes safe study participation.
- In the opinion of the Investigator, the Safety Monitor, or the Sponsor Study Monitor, has a history of severe renal or hepatic impairment, severe active hepatic disease, or other clinically significant medical condition that may preclude safe study participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinilabs Drug Development Corporation
Eatontown, New Jersey, 07724
About this study
Official title: A Randomized Double-blind, Placebo-controlled Single and Multiple Intravenous Ascending Dose Study of the Safety, Tolerability and Pharmacokinetics of GATE-101 in Normal Healthy Volunteers
To evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of GATE-101 in normal human volunteers
Read the detailed description
Single ascending dose (SAD), multiple ascending dose (MAD), double-blind placebo-controlled study in normal human volunteers.
Secondary objectives:
To evaluate the pharmacokinetics (PK) of GATE-101 following increasing single and multiple doses of intravenously (IV) administered GATE-101.
GATE-101 or Placebo: Dose/Mode of Administration: Single or 5 Daily Doses;Intravenous
- Conditions
- Major Depressive Disorder, Excessive Sleepiness
- Being tested
- GATE-101
- Keywords
- Major Depressive Disorder, Excessive Sleepiness, Metabotropic Glutamate Type 2/3 Receptor Antagonist
- Medical subject headings
- Depressive Disorder, Major, Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GATE-101Drug
GATE-101 is a metabotropic glutamate receptor type 2/3 antagonist
| Study group | Role | What they receive |
|---|---|---|
| GATE-101, 5 mg IV, Single Dose | Experimental | GATE-101, 5 mg IV, Single Dose, with follow up of 28 days Receives: Drug: GATE-101 |
| GATE-101, 15 mg IV, Single Dose | Experimental | GATE-101, 15 mg IV, Single Dose, with follow up of 28 days Receives: Drug: GATE-101 |
| GATE-101, 50 mg IV, Single Dose | Experimental | GATE-101, 50 mg IV, Single Dose, with follow up of 28 days Receives: Drug: GATE-101 |
| GATE-101, 150 mg IV, Single Dose | Experimental | GATE-101, 150 mg IV, Single Dose, with follow up of 28 days Receives: Drug: GATE-101 |
| GATE-101, 450 mg IV, Single Dose | Experimental | GATE-101, 450 mg IV, Single Dose, with follow up of 28 days Receives: Drug: GATE-101 |
| GATE-101, 15 mg IV, Single Dose, Lumbar Catheter | Experimental | GATE-101, 15 mg IV, Single Dose, with Lumbar Catheter for collection of cerebrospinal fluid (CSF) PK samples, with follow up of 28 days Receives: Drug: GATE-101 |
| GATE-101, 50 mg IV, Single Dose, Lumbar Catheter | Experimental | GATE-101, 50 mg IV, Single Dose, with Lumbar Catheter for collection of cerebrospinal fluid (CSF) PK samples, with follow up of 28 days Receives: Drug: GATE-101 |
| GATE-101 5 mg IV, Five Daily Doses | Experimental | GATE-101 5 mg IV, Five Daily Doses, with follow up for 28 days from first dose Receives: Drug: GATE-101 |
| GATE-101 15 mg IV, Five Daily Doses | Experimental | GATE-101 15 mg IV, Five Daily Doses, with follow up for 28 days from first dose Receives: Drug: GATE-101 |
| GATE-101 150 mg IV, Five Daily Doses | Experimental | GATE-101 150 mg IV, Five Daily Doses, with follow up for 28 days from first dose Receives: Drug: GATE-101 |
| Placebo Comparator, Single Dose | Placebo comparator | Placebo Comparator, Single Dose, with follow up for 28 days Receives: Drug: GATE-101 |
| Placebo Comparator, Five Daily Doses | Placebo comparator | Placebo Comparator, Five Daily Doses, with follow up for 28 days from first dose Receives: Drug: GATE-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment-Emergent Adverse Events Through Study Completion, 28 days
Safety and Tolerabiity
Measured: 28 Days
Secondary outcomes (4)
Pharmacokinetics - maximum plasma concentration - following a single intravenous dose
Maximum observed plasma concentration following a single dose
Measured: 72 hours
Pharmacokinetics - maximum plasma concentration - following 5 daily intravenous doses
Maximum observed plasma concentration following the fifth daily doses
Measured: 72 hours
Pharmacokinetics - area under the curve - following a single intravenous dose
Area under the concentration time curve from time 0 to infinity following a single dose
Measured: 72 hours
Pharmacokinetics - area under the curve - following 5 daily intravenous doses
Area under the concentration time curve from time 0 to infinity following the fifth daily dose
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start26 Oct 2020
- Primary completion13 Aug 2021
- Study completion13 Aug 2021
Why it stopped: Reached biomarker endpoint
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies 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
- Model description
- Parallel Assignment
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syndeio Biosciences, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ronald M Burch, MD, PhD, Study director, Syndeio Biosciences, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04618263
- Sponsor's protocol ID
- GATE-101-C-101
- Status last verified
- Aug 2022
- First submitted
- 31 Oct 2020
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-blind, Placebo-controlled Single and Multiple Intravenous Ascending Dose Study of the Safety, Tolerability and Pharmacokinetics of GATE-101 in Normal Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04618263
- Acronym / sponsor ID
- GATE-101-C-101
- Conditions
- Major Depressive Disorder, Excessive Sleepiness
- Keywords
- Major Depressive Disorder, Excessive Sleepiness, Metabotropic Glutamate Type 2/3 Receptor Antagonist
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Reached biomarker endpoint
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Syndeio Biosciences, IncIndustry (pharma, biotech, devices)
- Study start
- 26 Oct 2020 (actual)
- Primary completion
- 13 Aug 2021 (actual)
- Study completion
- 13 Aug 2021 (actual)
- First posted
- 5 Nov 2020 (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.
To evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of GATE-101 in normal human volunteers
Detailed description
Single ascending dose (SAD), multiple ascending dose (MAD), double-blind placebo-controlled study in normal human volunteers.
Secondary objectives:
To evaluate the pharmacokinetics (PK) of GATE-101 following increasing single and multiple doses of intravenously (IV) administered GATE-101.
GATE-101 or Placebo: Dose/Mode of Administration: Single or 5 Daily Doses;Intravenous
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 12
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| GATE-101, 5 mg IV, Single Dose | Experimental | Drug: GATE-101GATE-101, 5 mg IV, Single Dose, with follow up of 28 days |
| GATE-101, 15 mg IV, Single Dose | Experimental | Drug: GATE-101GATE-101, 15 mg IV, Single Dose, with follow up of 28 days |
| GATE-101, 50 mg IV, Single Dose | Experimental | Drug: GATE-101GATE-101, 50 mg IV, Single Dose, with follow up of 28 days |
| GATE-101, 150 mg IV, Single Dose | Experimental | Drug: GATE-101GATE-101, 150 mg IV, Single Dose, with follow up of 28 days |
| GATE-101, 450 mg IV, Single Dose | Experimental | Drug: GATE-101GATE-101, 450 mg IV, Single Dose, with follow up of 28 days |
| GATE-101, 15 mg IV, Single Dose, Lumbar Catheter | Experimental | Drug: GATE-101GATE-101, 15 mg IV, Single Dose, with Lumbar Catheter for collection of cerebrospinal fluid (CSF) PK samples, with follow up of 28 days |
| GATE-101, 50 mg IV, Single Dose, Lumbar Catheter | Experimental | Drug: GATE-101GATE-101, 50 mg IV, Single Dose, with Lumbar Catheter for collection of cerebrospinal fluid (CSF) PK samples, with follow up of 28 days |
| GATE-101 5 mg IV, Five Daily Doses | Experimental | Drug: GATE-101GATE-101 5 mg IV, Five Daily Doses, with follow up for 28 days from first dose |
| GATE-101 15 mg IV, Five Daily Doses | Experimental | Drug: GATE-101GATE-101 15 mg IV, Five Daily Doses, with follow up for 28 days from first dose |
| GATE-101 150 mg IV, Five Daily Doses | Experimental | Drug: GATE-101GATE-101 150 mg IV, Five Daily Doses, with follow up for 28 days from first dose |
| Placebo Comparator, Single Dose | Placebo comparator | Drug: GATE-101Placebo Comparator, Single Dose, with follow up for 28 days |
| Placebo Comparator, Five Daily Doses | Placebo comparator | Drug: GATE-101Placebo Comparator, Five Daily Doses, with follow up for 28 days from first dose |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Normal, healthy volunteer male and female subjects
- Aged 18 to 40 years
- For female subjects must meet one of the following:
- For male subjects, must meet one of the following:
- Body mass index (BMI) < 30
Key exclusion criteria (18 listed)
- Human immunodeficiency virus (HIV) infection, or hepatitis or other ongoing infectious disease
- Evidence of alcohol abuse (greater than 4 units of alcohol on most days; 1 unit = 1/2 pint of beer, 1 glass of wine or 1 oz. of spirits). Alcohol consumption should be avoided for at least 24 hours prior to baseline/dosing visit. A positive alcohol breathalyzer at screening and baseline visit
- Current abuse of illicit substances, using the Diagnostic and Statistical Manual (DSM) V definition of substance use disorder.
- Current cigarette/tobacco smoker or use of other tobacco or nicotine products including ecigarettes or vaping (if formerly a smoker must not have smoked for at least one year prior to enrolling in this study). Nonsmoking will be confirmed by cotinine assay.
- Currently pregnant, planning to become pregnant during the course of the study, or nursing mother
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 |
|---|---|---|
| GATE-101GATE-101 is a metabotropic glutamate receptor type 2/3 antagonist | Drug | GATE-101 15 mg IV, Five Daily Doses, GATE-101 150 mg IV, Five Daily Doses, GATE-101 5 mg IV, Five Daily Doses, GATE-101, 15 mg IV, Single Dose, GATE-101, 15 mg IV, Single Dose, Lumbar Catheter, GATE-101, 150 mg IV, Single Dose, GATE-101, 450 mg IV, Single Dose, GATE-101, 5 mg IV, Single Dose, GATE-101, 50 mg IV, Single Dose, GATE-101, 50 mg IV, Single Dose, Lumbar Catheter, Placebo Comparator, Five Daily Doses, Placebo Comparator, Single Dose |
Primary outcome
Number of Participants with Treatment-Emergent Adverse Events Through Study Completion, 28 days
Time frame: 28 Days
Safety and Tolerabiity
4 secondary outcomes
Pharmacokinetics - maximum plasma concentration - following a single intravenous dose
Time frame: 72 hours
Pharmacokinetics - maximum plasma concentration - following 5 daily intravenous doses
Time frame: 72 hours
Pharmacokinetics - area under the curve - following a single intravenous dose
Time frame: 72 hours
Pharmacokinetics - area under the curve - following 5 daily intravenous doses
Time frame: 72 hours
Results and safety
The study was stopped early (reason given: Reached biomarker endpoint). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
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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 M 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 GATE-101 in people with Major Depressive Disorder and Excessive Sleepiness, 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 11 inclusion and 18 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: stopped early, as of the sponsor's last update on 3 Aug 2022. 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. Some participants in this study may receive a placebo. 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?
The study was stopped early (reason given: Reached biomarker endpoint). Results are not available in the source record.
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?
Number of Participants with Treatment-Emergent Adverse Events Through Study Completion, 28 days (time frame: 28 Days). 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 3 Aug 2022.