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

NCT ID: NCT05921929

Last Updated: 2024-05-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-02
• Study Completion Date: 2024-05-02

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.

Conditions

PTSD; Alzheimer Disease; Brain Diseases; Neuro-Degenerative Disease; Major Depressive Disorder; Treatment Resistant Depression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

One single oral dose per participant

Group Type: EXPERIMENTAL

Fluoroethylnormemantine (FENM)

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

ReST Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU of Liège - Clinical Pharmacology Unit

Liège, , Belgium

Countries

Belgium

Other Identifiers

RT-IS-G-H-2301

Identifier Type: -

Identifier Source: org_study_id