First-In-Human (FIH), Single Ascending Dose (SAD) Study of FluoroEthylNorMemantine (FENM)

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Primary Purpose

Status

Not yet recruiting

Phase

Phase 1

Locations

Belgium

Study Type

Interventional

Intervention

Fluoroethylnormemantine (FENM)

About this trial

This is an interventional other trial for PTSD focused on measuring NMDA, PTSD, Alzheimer's disease, Brain Diseases, Neuro-Degenerative Disease, Major Depressive Disorder, Treatment Resistant Depression

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

CHU of Liège - Clinical Pharmacology Unit

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

One single oral dose per participant

Arm Description

Outcomes

Primary Outcome Measures

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Secondary Outcome Measures

To assess maximum plasma concentration [Cmax]

To assess time to Cmax [Tmax]

To assess minimum concentration within the dosing interval [Cmin]

To assess last observed plasma concentration [Clast]

To assess time of the minimum concentration [Tmax]

To assess area under the plasma concentration-time curve from 0 to the end of the dose interval [AUC 0-tau]

To assess area under the plasma concentration-time curve from dosing (time 0) to the time of last measured concentration [AUC 0-last]

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-∞]

To assess terminal half-life, apparent elimination half-life [T1/2]

To assess apparent oral clearance [CL/F]

To assess apparent volume of distribution [Vz/F]

To assess preliminary exploratory time course of Brain Disease Neurotrophic Factor plasmatic levels of single ascending doses of the FENM

Full Information

NCT ID

NCT05921929

First Posted

June 6, 2023

Last Updated

June 23, 2023

Sponsor

ReST Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT05921929

Brief Title

First-In-Human (FIH), Single Ascending Dose (SAD) Study of FluoroEthylNorMemantine (FENM)

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

September 2023 (Anticipated)

Primary Completion Date

September 2024 (Anticipated)

Study Completion Date

September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ReST Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

One single oral dose per participant

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Fluoroethylnormemantine (FENM)

Intervention Description

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.

Primary Outcome Measure Information:

Title

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)

Secondary Outcome Measure Information:

Title

To assess maximum plasma concentration [Cmax]

Time Frame