A Study Assessing the Safety and Pharmacokinetic Profile of Modified Release Formulations of Tolcapone

Inclusion criteria

• Healthy males or non-pregnant, non-lactating healthy females
• Age 18 to 65 years of age at the time of signing informed consent
• Body mass index (BMI) of 18.0 to 32.0 kg/m2 or, if outside the range, considered not clinically significant by the investigator
• 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

Exclusion criteria

• Subjects who have received any IMP in a clinical research study within the previous 3 months prior to first dose.
• Subjects who are study site employees, or immediate family members of a study site or sponsor employee.
• Subjects who have previously been enrolled in this study.
• History of any drug or alcohol abuse in the past 2 years.
• Current smokers and those who have smoked within the last 12 months. A breath carbon monoxide reading of greater than 10 ppm at screening
• Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
• Females of childbearing potential who are pregnant or lactating
• Subjects who do not have suitable veins for multiple venepunctures / cannulation as assessed by the investigator at screening
• Clinically significant abnormal biochemistry, hematology or urinalysis as judged by the investigator
• Hemoglobin below the lower limit of normal
• ALT or AST outside the normal reference range at screening or admission.
• Confirmed positive drugs of abuse test result
• Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
• History of clinically significant cardiovascular, neurological, renal, hepatic, chronic respiratory or gastrointestinal disease, or psychiatric disorder, as judged by the investigator
• Subjects with a history of cholecystectomy or gall stones
• Serious adverse reaction or serious hypersensitivity to any drug, the formulation excipients, or lactose intolerance
• Presence or history of clinically significant allergy requiring treatment, as judged by the investigator.
• Donation or loss of greater than 400 mL of blood within the previous 3 months
• Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies in the 14 days before IMP administration.
• Contraindication for Tasmar®
• Failure to satisfy the investigator of fitness to participate for any other reason

NOTE: Other inclusion/exclusion criteria may apply, per protocol