Effect of Food on Opicapone

Exclusion Criteria

• •Clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders.
• •Clinically relevant surgical history.
• •Clinically relevant abnormality in the coagulation tests.
• •Clinically relevant abnormality in the liver function tests.
• •History of relevant atopy or drug hypersensitivity, particularly to any COMT inhibitor.
• •History of alcoholism or drug abuse.
• •Consume more than 14 units of alcohol a week.
• •Significant infection or known inflammatory process at screening or admission.
• •Acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission.
• •Used medicines within 2 weeks of admission that may affect the safety or other study assessments, in the investigator's opinion.
• •Previously received OPC.
• •Used any investigational drug or participated in any clinical trial within 90 days prior to screening.
• •Participated in more than 2 clinical trials within the 12 months prior to screening.
• •Donated or received any blood or blood products within the 3 months prior to screening.
• •Vegetarians, vegans or have medical dietary restrictions.
• •Cannot communicate reliably with the investigator.
• •Unlikely to co-operate with the requirements of the study.
• •If female:
• •Pregnant or breast-feeding.
• •Of childbearing potential and not used an approved effective contraceptive method or she uses oral contraceptives.