Pharmacokinetic Study of MIN-101 in Healthy Subjects

Inclusion Criteria:

• Healthy males (Part 1 and Part 2) or non-pregnant, non-lactating healthy females (Part 2 only)
• Body mass index (BMI) of 18.0 to 30.0 kg/m2
• Must be CYP2D6 Extensive metabolizer
• Must be willing and able to communicate and participate in the whole study
• Must provide written informed consent
• Must agree to use an adequate method of contraception

Key Exclusion Criteria:

• Subjects who have QTc > 430 in male, > 450 in female confirmed by a repeat ECG
• Any family history of sudden cardiac death and Torsade de Points
• No personal or family history of unexplained presyncope, syncope or orthostatic hypotension
• History of any drug or alcohol abuse in the past 2 years
• History or evidence of any medically diagnosed clinically significant psychiatric disorders
• Suicidal tendencies or history of suicidal attempts
• 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)
• Current smokers and those who have smoked within the last 12 months. A breath carbon monoxide reading of greater than 10 ppm at screening
• Females of childbearing potential who are pregnant or lactating (female subjects must have a negative urine pregnancy test at admission)
• Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator
• Positive drugs of abuse test result
• Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results