Study of Harmine in Healthy Subjects

Exclusion Criteria

• •Children under the age of 18 and adults over the age of 55 due to concerns regarding neurodevelopmental and neurocognitive effects, respectively.
• •Individuals who are underweight as defined as a BMI \<19, or who are obese as defined as \>30 according to the Centers for Disease Control (CDC). These criteria are in line with the goals of a phase I dose finding and pharmacokinetic study.
• •Presence of a significant medical illness i.e., delirium, metastatic cancer, decompensated cardiac, liver or kidney failure, major surgery, stroke or myocardial infarction during the three months prior to entry;
• •Presence of a significant neurological disease such as Parkinson's disease, primary or secondary seizure disorders, intracranial tumors, severe head trauma; neurodegenerative diseases;
• •Presence of neurocognitive or dementing disorders;
• •Presence or history of psychiatric disorder as diagnosed by Mini Neuropsychiatric Interview (MINI);
• •Urine toxicology positive for illicit drugs or dis-allowed concomitant medications as per study protocol;
• •Medications with primary central nervous system (CNS) effects are dis-allowed, including psychotropic medications, antidepressants, benzodiazepines, centrally acting hypnotic agents, and centrally acting anti-migraine therapies;
• •Medications with primary cardiovascular effects are dis-allowed, including beta-adrenergic antagonists, ACE inhibitors, calcium channel blockers, and diuretics;
• •Any OTC medications or herbal remedies (see concomitant medications listed above) that could interfere with the study drug, pose a risk to the subject, or contain high tyramine as outlined in the Low Tyramine Diet attachment and above in the concomitant medication summary;
• •Any other medications that, in the opinion of the investigators, would pose a safety risk to the patient or that would interfere with the interpretation of study results; Positive pregnancy test at screen or on the morning of the treatment day in women of childbearing potential;
• •Systolic blood pressure outside the range of 100 - 140 mmHg, diastolic blood pressure outside the range of 60 - 90 mmHg, and pulse rate at rest \> 100 or \< 60 bpm;
• •History of positive tests for hepatitis B surface antigen, hepatitis C antibodies;
• •History of HIV;
• •Significant ECG abnormalities as follows:
• •Heart Rate \< 60 and \>100 bpm
• •PR Interval \<120 and \> 220 ms
• •QRS duration \< 70 and \>120 ms
• •QTC Interval (Bazett) \> 450 ms