A Food Effect Open-Label, Randomized Study Assessing the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of OV4071 in Healthy Male and Female Participants.

Exclusion Criteria1

• history or presence of gastritis, gastrointestinal tract disorder, gastric bypass surgery, or hepatic disorder or other clinical condition which, in the opinion of the Principal Investigator or designee, may affect the absorption, distribution, metabolism, or elimination of study drug. History of cholecystectomy and diagnosis of Gilberts syndrome is also exclusionary. 2. Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, psychiatric disorder, or loss of consciousness (LOC) due to head injury for longer than 30 minutes (Moderate traumatic Brain Injury) as determined by the Principal Investigator (or designee). 3. Renal clearance defined as an average of less than 60 ml/min using the Cockroft and Gault formula. 4. History or presence of alcohol or drug abuse within the past 2 years prior to screening visit as determined by the Principal Investigator (or designee) and guidance. Drug and alcohol tests will be conducted at Screening and on D-1 and may be repeated during the trial at the discretion of the PI. 5. history or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds. 6. Risk of suicide according to the Principal Investigator's or delegate's clinical judgement (e.g. per C-SSRS) or has made a suicide attempt in the previous year prior to Screening visit. 7. Unable to refrain from or anticipated use of: a. Any (oral and non-oral) systemic drug including prescription (with exception of non-oral highly effective contraception) and nonprescription medications, herbal remedies, or vitamin supplements within 14 days prior to the first dosing and throughout the study, including the follow-up period. After the first dose of study drug, paracetamol/acetaminophen (up to 2 g per 24 hours) may be administered at the discretion of the Principal Investigator or designee. b. Alcohol, caffeinated and dietary products such as grapefruit, Seville oranges etc. c. Any product, remedy, supplement, or medication containing cannabidiols (CBD), Tetrahydrocannabinol 9THC) or related compounds within 30 days prior to the first dosing and throughout the study, including the follow-up period. 8. Has been on a diet incompatible with the on-study diet with the phase of the study to which they are enrolled (Part A, B, or C), in the opinion of the Investigator or designee, within the 30 days prior to the first dosing and throughout the study. 9. Participation in another clinical study within 30 days prior to the first dose. The 30 days window will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to D1 of the current study. If the previous investigational product has a long half-life, three months or five half-lives (whichever is longer) should have passed; participation in a clinical trial involving an investigational product or nonapproved use of a drug or device (other than the investigational product used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. 10. Receipt of vaccination (inclusive of influenza and SARS COV2) within 14 days of dosing (D1). 11. If male, the participant intends to donate sperm during the course of the study or for 90 days following the last dose of study drug. 12. If female, the participant is pregnant or intending to become pregnant before participating in this study, during the study, and within 1 month after last dose of the study drug; or intending to donate ova during such time period; or lactating. 13. Ovid employees or Investigator site personnel where the study is being conducted and/or their immediate family. Note: immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. 14. Participants who have Obstructive Sleep Apnea or any other conditions that can cause daytime somnolence, including individuals who work night shifts or who are otherwise typically nocturnal. Any other contraindications for the EEG procedures per discretion of the PI. 15. Individuals who, in the opinion of the Investigator or designee should not participate in this study. 16. Taking medications that are CYP2C8 and CYP3A4 strong inhibitors or inducers; or a sensitive substance for P-gp, BCRP or MATE1 and 2-K transporters, especially those with narrow Therapeutic Window.