← Trials/Trial dossier/NCT05921929

WithdrawnPhase 1

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

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

Lead sponsor

ReST Therapeutics

Asset

Fluoroethylnormemantine (FENM)

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Age 18-45•Male

Primary endpoint

•Treatment-related adverse events

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05921929

Org study IDRT-IS-G-H-2301

Timeline

Milestones

Study first posted2023-06-27actual

Study start2024-05-02actual

Primary completion2024-05-02actual

Study completion2024-05-02actual

Last update posted2024-05-03actual

Assets

Drug assets

Fluoroethylnormemantine (FENM)

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years

Maximum age45 Years

SexMale

Healthy volunteersAccepted

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.

Endpoints (13)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Other (unclassified)

Safety / tolerability / PK

9 endpoints

Primary/protocol endpoint

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)

event count, event

Secondary/protocol endpoint

To assess maximum plasma concentration [Cmax]