Food Effect and Bioequivalence Study of Simufilam Tablets in Healthy Volunteers

Inclusion Criteria

• Male or female subjects, Ages ≥ 18 and ≤ 45 years
• BMI of 18 - 30 Kg/m²
• Informed consent form (ICF) signed by the subject
• General health status acceptable for participation in the study as determined by medical history, review of current medication, physical examination, and laboratory results
• Fluency (oral and written) in English
• The patient must agree to comply with the drawing of blood samples for the PK assessments, laboratory assessments and plasma biomarkers
• The subject is willing and able to remain at the study site for the duration of the study

Exclusion Criteria

• The subject has any relevant deviations from normal in physical examination, electrocardiogram (ECG), or clinical laboratory tests, as evaluated by the investigator.
• The subject has had a clinically significant illness within 30 days of this study.
• The subject has a history of significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, or metabolic disease.
• Subject is taking prescription CNS medication.
• The subject has used alcohol, grapefruit, grapefruit juice, caffeine or xanthinecontaining products 48 h before dosing or intends to use any of these products during the study.
• The subject has a history of substance abuse or a current positive ethanol breath test or positive urine drug screen.
• The subject has a positive serum hepatitis B surface antigen or positive HCV antibody test.
• The subject has a positive HIV test.
• The subject has a current positive urine cotinine test.
• The subject has participated in another drug study in the past 30 days.
• The subject has donated or lost a significant volume of blood (>450 mL) within 4 weeks of the study.
• The subject is unwilling to reside in the study unit for the duration of the study or to cooperate fully with the investigator or site personnel.
• Covid-19 infection within the past 3 months