A Sequential Two-Part, Open-Label Study in Healthy Male and Female Subjects

Exclusion Criteria

• •1. Participation in a clinical research study within the previous 3 months
• •2. Subjects who are study site employees, or immediate family members of a study site or sponsor employee
• •3. Subjects who have previously been enrolled in this study
• •4. History of any drug or alcohol abuse in the past 2 years
• •5. Regular alcohol consumption in males \>21 units per week and females \>14 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
• •6. Current smokers and those who have smoked within the last 12 months. A breath carbon monoxide reading of greater than 10 ppm at screening
• •7. Females of childbearing potential who are pregnant or lactating (female subjects must have a negative urine pregnancy test at admission)
• •8. Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator (laboratory parameters are listed in Appendix 1)
• •9. Positive drugs of abuse test result (drugs of abuse tests are listed in Appendix 1)
• •10. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
• •11. Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening
• •12. History of cardiovascular, renal, hepatic, chronic respiratory or GI disease as judged by the investigator
• •13. Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
• •14. Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hayfever is allowed unless it is active
• •15. Donation or loss of greater than 400 mL of blood within the previous 3 months
• •16. Subjects who are taking, or have taken, any prescribed or over-the-counter drug (other than 4 g per day paracetamol, hormone replacement therapy and hormonal contraception) or herbal remedies in the 14 days before IMP administration (See Section 11.4). Exceptions may apply on a case by case basis if considered not to interfere with the objectives of the study as agreed by the PI and sponsor's medical monitor
• •17. Use of any non-selective monoamine oxidase (MAO) inhibitors within 2 weeks of screening
• •18. History or presence of glaucoma
• •19. History or presence of suspicious undiagnosed skin lesions or a history of melanoma
• •20. Any history of psychoses or seizure
• •21. Known hypersensitivity to Sinemet® or domperidone or any of the excipients
• •22. Any history or presence of Prolactin-releasing pituitary tumour (prolactinoma)
• •23. Any medical history of GI haemorrhage, mechanical obstruction or perforation
• •24. Any history of moderate or severe hepatic impairment
• •25. Subjects with clinically significant liver function tests
• •26. Subjects with QTc \>450 ms at screening
• •27. Subjects with significant electrolyte disturbances
• •28. Subjects with any underlying cardiac disease
• •29. Subjects who have received QT-prolonging drugs or potent cytochrome P450 (CYP) 3A4 inhibitors within 4 weeks of screening
• •30. ND0612H arm only: Subjects who have sinus problems
• •31. ND0612H arm only: Subjects who have regular heartburn and/or indigestion
• •32. ND0612H arm only: Subjects who have had abdominal (bowel) surgery
• •33. ND0612H arm only: Any clinically significant findings observed during naso-jejunal tube placement as determined by the endoscopist
• •34. Failure to satisfy the investigator of fitness to participate for any other reason