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

Ki vehet részt

• 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

Ki nem vehet részt

• history of febrile illness within 5 days prior to administration,
• using of prescription drugs, vaccine, routine or as needed consumption of medications or herbal supplements,
• 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
• any condition possibly affecting drug absorption,
• 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,
• 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,