Intervention: Opicapone
Trial phase: Phase 1
ATC code: N04BX04
SMILES: Cc1c(Cl)c(C)[n+]([O-])c(Cl)c1-c1noc(-c2cc(O)c(O)c([N+](=O)[O-])c2)n1
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: 100 mg OPC

OPC: The drug substance of 100 mg OPC was administered as 1 capsule.
Eligibility criteria:
Inclusion Criteria:

Gender: male
Age: 18 - 55 years, inclusive
Body Mass Index (BMI): 18.0 - 30.0 kg/m2, inclusive Body weight (kg)and height2 (m2)
Ability and willingness to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, "powerdrinks") and grapefruit (juice) from 48 hours prior to entry in the clinical research centre until discharge
Medical history without major pathology
Resting supine blood pressure and a resting pulse rate showing no clinically relevant deviations as judged by the MI
Computerised (12-lead) electrocardiogram (ECG) recording without signs of clinically relevant pathology or showing no clinically relevant deviations as judged by the MI
Willingness to use adequate contraception from the time of dosing until 3 months after the follow-up visit
All values for haematology and for clinical chemistry tests of blood and urine within the normal range or showing no clinically relevant deviations as judged by the MI
Willingness to sign the written ICF

Exclusion Criteria:

Evidence of clinically relevant pathology
Mental handicap
History of relevant drug and/or food allergies
Regular/routine treatment with non-topical medications within 30 days prior to entrance into the clinical research centre
Smoking (less than 60 days prior to drug administration)
History of alcohol abuse or drug addiction (including soft drugs like cannabis products)
Use of concomitant medication, except for acetaminophen (paracetamol), which was allowed up to 3 days before entrance into the clinical research centre. Multivitamins and vitamin C were allowed up to 7 days before entrance into the clinical research centre. All other medication (including over the counter medication, health supplements, and herbal remedies such as St. John's wort extract) was to be stopped at least 14 days prior to entrance into the clinical research centre
Participation in a drug study within 60 days prior to drug administration. Participation in more than 3 other drug studies in the 10 months preceding administration of study drug
Donation of more than 50 mL of blood within 60 days prior to drug administration. Donation of more than 1.5 litres of blood in the 10 months preceding administration of study drug
Participation in another ADME study with a radiation burden -0.1 mSv in the period of 1 year before the start of the study
Exposure to radiation for diagnostic reasons (except dental X-rays and plain X rays of thorax and bony skeleton - excluding spinal column), during work or during participation in a medical study in the previous year
Irregular defecation pattern (less than once per 2 days)
Positive screen on drugs of abuse (opiates, methadone, cocaine, amphetamines, cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants and alcohol)
Intake of more than 24 units of alcohol per week (1 unit of alcohol equals approximately 250 mL of beer, 100 mL of wine or 35 mL of spirits)
Positive screen on hepatitis B surface antigen (HBsAg)
Positive screen on anti-hepatitis C virus (HCV)
Positive screen on anti- human immunodeficiency virus (HIV) 1/2
Illness within 5 days prior to drug administration