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

ReST Therapeutics

Status and phase

Withdrawn

Phase 1

Conditions

Neuro-Degenerative Disease

Major Depressive Disorder

Alzheimer Disease

Treatment Resistant Depression

PTSD

Brain Diseases

Treatments

Drug: Fluoroethylnormemantine (FENM)

Study type

Interventional

Funder types

Industry

Identifiers

NCT05921929

RT-IS-G-H-2301

Details and patient eligibility

About

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.

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts 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.