PTSDPhase 1NCT05921929
First-In-Human (FIH), Single Ascending Dose (SAD) Study of FluoroEthylNorMemantine (FENM)
A Phase 1 study testing Fluoroethylnormemantine (FENM) in people with PTSD and Alzheimer Disease, run by ReST Therapeutics at 1 site in Belgium.
Trial summary
The goal of this First-In-Human (FIH) trial is to learn about safety and PharmacoKinetics (PK) in healthy adult volunteers. The main questions it aims to answer are: What is the safety of single ascending doses of the FluoroEthylNorMemantine (FENM)? What is the PK profile of single ascending doses of the FENM in… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- PTSD, Alzheimer Disease, Brain Diseases
- What is being tested?
- Fluoroethylnormemantine (FENM)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBelgium
- Study dates
- 2 May 2024to 2 May 2024
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- willing and able to sign written informed consent,
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2, a total body weight >65 kg,
- efficient contraceptive mean,
- no major psychiatric disorder per the Mini-International Neuropsychiatric Interview (MINI) questionnaire,
- normal laboratory tests results, arterial Blood Pressure/pulse rate, 12-lead Electrocardiogram recording.
Who cannot join
- evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, allergic disease including drug allergies, or other severe acute or chronic medical or psychiatric condition or laboratory abnormality,
- history of febrile illness within 5 days prior to administration,
- any condition possibly affecting drug absorption,
- using of prescription drugs, vaccine, routine or as needed consumption of medications or herbal supplements,
- having positive serology, positive urine test for drugs of abuse, a general medical or psychological condition or behavior, including current substance dependence or abuse,
- history of drug or alcohol abuse within 1 year before screening,
- consuming currently of nicotine containing products, any food or any beverage containing grapefruit or grapefruit juice within 48 h prior to administration,
- having blood donation or loss of significant amount of blood within 2 months prior to study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Pharmacokinetics of a Novel NMDA Receptor Antagonist Against Brain Related Diseases in Healthy Adult Volunteers: First-in-human, Phase I, Single Dose-escalating, Open Label Study
The goal of this First-In-Human (FIH) trial is to learn about safety and PharmacoKinetics (PK) in healthy adult volunteers. The main questions it aims to answer are:
- What is the safety of single ascending doses of the FluoroEthylNorMemantine (FENM)?
- What is the PK profile of single ascending doses of the FENM in human?
- What is the preliminary exploratory time course of Brain Disease Neurotrophic Factor (BDNF) plasmatic levels of single ascending doses of the FENM? Participants will receive one single oral dose of FENM.
- Conditions
- PTSD, Alzheimer Disease, Brain Diseases, Neuro-Degenerative Disease, Major Depressive Disorder, Treatment Resistant Depression
- Being tested
- Fluoroethylnormemantine (FENM)
- Keywords
- NMDA, PTSD, Alzheimer's disease, Brain Diseases, Neuro-Degenerative Disease, Major Depressive Disorder, Treatment Resistant Depression
- Medical subject headings
- Stress Disorders, Post-Traumatic, Alzheimer Disease, Brain Diseases, Depressive Disorder, Major, Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluoroethylnormemantine (FENM)Drug
Single ascending oral dose administration according to the following scheme: 20, 40, 80, 120-160, 200-240, 260-320mg/kg (six dose levels). The three upper dose levels to be administered (120-160, 200-240, 260-320mg/kg) will be precisely determined with the data collected at the end of the first three dose levels administered.
| Study group | Role | What they receive |
|---|---|---|
| One single oral dose per participant | Experimental | Not described Receives: Drug: Fluoroethylnormemantine (FENM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: From single dose administration to the end of the study follow-up (2 weeks later)
Secondary outcomes (12)
To assess maximum plasma concentration [Cmax]
Measured: At pre-dose and at 2, 4, 6, 8, 10, 12, 24, 48, 96, 189, 264 and 336hours post-dose
To assess time to Cmax [Tmax]
Measured: At pre-dose and at 2, 4, 6, 8, 10, 12, 24, 48, 96, 189, 264 and 336hours post-dose
To assess minimum concentration within the dosing interval [Cmin]
Measured: At pre-dose and at 2, 4, 6, 8, 10, 12, 24, 48, 96, 189, 264 and 336hours post-dose
To assess last observed plasma concentration [Clast]
Measured: At pre-dose and at 2, 4, 6, 8, 10, 12, 24, 48, 96, 189, 264 and 336hours post-dose
To assess time of the minimum concentration [Tmax]
Measured: At pre-dose and at 2, 4, 6, 8, 10, 12, 24, 48, 96, 189, 264 and 336hours post-dose
To assess area under the plasma concentration-time curve from 0 to the end of the dose interval [AUC 0-tau]
Measured: At pre-dose and at 2, 4, 6, 8, 10, 12, 24, 48, 96, 189, 264 and 336hours post-dose
To assess area under the plasma concentration-time curve from dosing (time 0) to the time of last measured concentration [AUC 0-last]
Measured: At pre-dose and at 2, 4, 6, 8, 10, 12, 24, 48, 96, 189, 264 and 336hours post-dose
To assess total area under the plasma concentration-time curve from dosing (time 0) taken to the limit as the end time becomes arbitrarily large (infinity) [AUC 0-∞]
Measured: At pre-dose and at 2, 4, 6, 8, 10, 12, 24, 48, 96, 189, 264 and 336hours post-dose
To assess terminal half-life, apparent elimination half-life [T1/2]
Measured: At pre-dose and at 2, 4, 6, 8, 10, 12, 24, 48, 96, 189, 264 and 336hours post-dose
To assess apparent oral clearance [CL/F]
Measured: At pre-dose and at 2, 4, 6, 8, 10, 12, 24, 48, 96, 189, 264 and 336hours post-dose
To assess apparent volume of distribution [Vz/F]
Measured: At pre-dose and at 2, 4, 6, 8, 10, 12, 24, 48, 96, 189, 264 and 336hours post-dose
To assess preliminary exploratory time course of Brain Disease Neurotrophic Factor plasmatic levels of single ascending doses of the FENM
Measured: At pre-dose, at Cmax (estimated at 6-8hours post-dose) and at 48, 72 and 264hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start2 May 2024
- Primary completion2 May 2024
- Study completion2 May 2024
Why it stopped: a new trial should be designed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- ReST Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05921929
- Sponsor's protocol ID
- RT-IS-G-H-2301
- Status last verified
- May 2024
- First submitted
- 6 Jun 2023
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Pharmacokinetics of a Novel NMDA Receptor Antagonist Against Brain Related Diseases in Healthy Adult Volunteers: First-in-human, Phase I, Single Dose-escalating, Open Label Study
- ClinicalTrials.gov ID
- NCT05921929
- Acronym / sponsor ID
- RT-IS-G-H-2301
- Conditions
- PTSD, Alzheimer Disease, Brain Diseases, Neuro-Degenerative Disease, Major Depressive Disorder, Treatment Resistant Depression
- Keywords
- NMDA, PTSD, Alzheimer's disease, Brain Diseases, Neuro-Degenerative Disease, Major Depressive Disorder, Treatment Resistant Depression
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: a new trial should be designed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ReST TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 2 May 2024 (actual)
- Primary completion
- 2 May 2024 (actual)
- Study completion
- 2 May 2024 (actual)
- First posted
- 27 Jun 2023 (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 goal of this First-In-Human (FIH) trial is to learn about safety and PharmacoKinetics (PK) in healthy adult volunteers. The main questions it aims to answer are:
- What is the safety of single ascending doses of the FluoroEthylNorMemantine (FENM)?
- What is the PK profile of single ascending doses of the FENM in human?
- What is the preliminary exploratory time course of Brain Disease Neurotrophic Factor (BDNF) plasmatic levels of single ascending doses of the FENM? Participants will receive one single oral dose of FENM.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One single oral dose per participant | Experimental | Drug: Fluoroethylnormemantine (FENM) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- willing and able to sign written informed consent,
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2, a total body weight >65 kg,
- efficient contraceptive mean,
- no major psychiatric disorder per the Mini-International Neuropsychiatric Interview (MINI) questionnaire,
- normal laboratory tests results, arterial Blood Pressure/pulse rate, 12-lead Electrocardiogram recording.
Key exclusion criteria (8 listed)
- evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, allergic disease including drug allergies, or other severe acute or chronic medical or psychiatric condition or laboratory abnormality,
- history of febrile illness within 5 days prior to administration,
- any condition possibly affecting drug absorption,
- using of prescription drugs, vaccine, routine or as needed consumption of medications or herbal supplements,
- having positive serology, positive urine test for drugs of abuse, a general medical or psychological condition or behavior, including current substance dependence or abuse,
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 |
|---|---|---|
| Fluoroethylnormemantine (FENM)Single ascending oral dose administration according to the following scheme: 20, 40, 80, 120-160, 200-240, 260-320mg/kg (six dose levels). The three upper dose levels to be administered (120-160, 200-240, 260-320mg/kg) will be precisely determined with the data collected at the end of the first three dose levels administered. | Drug | One single oral dose per participant |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: From single dose administration to the end of the study follow-up (2 weeks later)
12 secondary outcomes
To assess maximum plasma concentration [Cmax]
Time frame: At pre-dose and at 2, 4, 6, 8, 10, 12, 24, 48, 96, 189, 264 and 336hours post-dose
To assess time to Cmax [Tmax]
Time frame: At pre-dose and at 2, 4, 6, 8, 10, 12, 24, 48, 96, 189, 264 and 336hours post-dose
To assess minimum concentration within the dosing interval [Cmin]
Time frame: At pre-dose and at 2, 4, 6, 8, 10, 12, 24, 48, 96, 189, 264 and 336hours post-dose
To assess last observed plasma concentration [Clast]
Time frame: At pre-dose and at 2, 4, 6, 8, 10, 12, 24, 48, 96, 189, 264 and 336hours post-dose
To assess time of the minimum concentration [Tmax]
Time frame: At pre-dose and at 2, 4, 6, 8, 10, 12, 24, 48, 96, 189, 264 and 336hours post-dose
To assess area under the plasma concentration-time curve from 0 to the end of the dose interval [AUC 0-tau]
Time frame: At pre-dose and at 2, 4, 6, 8, 10, 12, 24, 48, 96, 189, 264 and 336hours post-dose
To assess area under the plasma concentration-time curve from dosing (time 0) to the time of last measured concentration [AUC 0-last]
Time frame: At pre-dose and at 2, 4, 6, 8, 10, 12, 24, 48, 96, 189, 264 and 336hours post-dose
To assess total area under the plasma concentration-time curve from dosing (time 0) taken to the limit as the end time becomes arbitrarily large (infinity) [AUC 0-∞]
Time frame: At pre-dose and at 2, 4, 6, 8, 10, 12, 24, 48, 96, 189, 264 and 336hours post-dose
To assess terminal half-life, apparent elimination half-life [T1/2]
Time frame: At pre-dose and at 2, 4, 6, 8, 10, 12, 24, 48, 96, 189, 264 and 336hours post-dose
To assess apparent oral clearance [CL/F]
Time frame: At pre-dose and at 2, 4, 6, 8, 10, 12, 24, 48, 96, 189, 264 and 336hours post-dose
To assess apparent volume of distribution [Vz/F]
Time frame: At pre-dose and at 2, 4, 6, 8, 10, 12, 24, 48, 96, 189, 264 and 336hours post-dose
To assess preliminary exploratory time course of Brain Disease Neurotrophic Factor plasmatic levels of single ascending doses of the FENM
Time frame: At pre-dose, at Cmax (estimated at 6-8hours post-dose) and at 48, 72 and 264hours post-dose
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Fluoroethylnormemantine (FENM) in people with PTSD and Alzheimer Disease, run by ReST Therapeutics at 1 site in Belgium.
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 5 inclusion and 8 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: withdrawn, as of the sponsor's last update on 3 May 2024. 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 Belgium. 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?
The study was withdrawn before enrolling participants, so there are no results.
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-related adverse events as assessed by CTCAE v4.0 (time frame: From single dose administration to the end of the study follow-up (2 weeks later)). 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 May 2024.