A First in Human Study to Assess the Safety, Tolerability and Pharmacokinetics of ONO-2808-01 in Healthy Participants

Exclusion Criteria

• •1. Mentally or legally incapacitated or with significant emotional problems at the time of the Screening visit or expected during the conduct of the study.
• •2. History or presence of clinically significant medical, surgical or psychiatric condition (including history of suicidal behaviour) or objection by General Practitioner (GP) to participant entering trial.
• •3. Liver chemistry values above the upper limit of normal (ULN) at Screening or admission.
• •4. Sensitivity to the study drug.
• •5. Female who is pregnant or lactating or of childbearing potential.
• •6. History or presence of alcoholism or drug/chemical/substance abuse.
• •7. Evidence of poor venous access as assessed by PI.
• •8. Use of any medication which may affect ONO-2808 pharmacokinetics or pharmacodynamics
• •9. Current smoker or has smoked (including use of tobacco and/or nicotine-containing products) in the previous 3 months
• •10. Positive urine drugs of abuse, cotinine or alcohol results at Screening or admission.
• •11. Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
• •12. Supine resting blood pressure less than 90/40 millimeter of mercury (mmHg) or greater than 140/90 mmHg (Part A\& C) and less than 90/40 mmHg or greater than 160/90 mmHg (Part B).
• •13. Supine resting pulse rate lower than 40 beats per minute (bpm) or higher than 100 bpm.
• •14. Clinically significant history or presence of ECG findings at screening.
• •15. Use of any drug, including prescription and non-prescription medications, herbal remedies, or vitamin supplements within 14 days or five half-lives (whichever is longer) of first dosing and throughout the study.
• •16. Consumption or intake of compounds, food or fluids that are known to be a substrate, inducer or inhibitor of CYP450 for 28 days prior to the first dosing and throughout the study.
• •17. Donation of blood or significant blood loss within 56 days prior to the first dosing, or plasma donation within 7 days prior to the first dosing.
• •18. Participation in another clinical study within the last 3 months (or 5 half-lives of the study drug, whichever is longer) prior to the first dosing.
• •19. Objection by PI
• •20. Participants who are not willing to eat a high fat breakfast
• •21. History of significant back pain, significant kyphosis and or scoliosis or other spinal column deformities.
• •22. History or evidence of fundoscopy suggestive of raised intracranial pressure.
• •23. History or presence of any allergy or contraindication to the local anaesthetic required for participants undergoing lumbar puncture.