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

Phase

Condition

Depression (Major/severe)

Multiple Sclerosis

Post-traumatic Stress Disorders

Treatment

Fluoroethylnormemantine (FENM)

Clinical Study ID

NCT05921929

RT-IS-G-H-2301

Ages 18-45
Male
Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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-leadElectrocardiogram recording.

Exclusion

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 orpsychiatric 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 medicationsor herbal supplements,
having positive serology, positive urine test for drugs of abuse, a general medical orpsychological 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 beveragecontaining grapefruit or grapefruit juice within 48 h prior to administration,
having blood donation or loss of significant amount of blood within 2 months prior tostudy.

Study Design