An Open-label Study in Healthy Male Subjects to Assess the Absorption, Distribution, Metabolism and Excretion of [14C]-Labelled BIA 9-1067 and Metabolites
Condition: Parkinson's Disease (PD)
MeSH terms: Parkinson Disease
Intervention: OPC
Intervention description: The drug substance of 100 mg OPC was administered as 1 capsule.
Intervention MeSH terms: Opicapone
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Parkinson's disease (PD); BIA 9-1067; Opicapone

Summary:

      The purpose of this study is to determine the rate and routes of excretion of OPC and the
      mass balance in urine, faeces and expired air.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Gender: male

          2. Age: 18 - 55 years, inclusive

          3. Body Mass Index (BMI): 18.0 - 30.0 kg/m2, inclusive Body weight (kg)and height2 (m2)

          4. 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

          5. Medical history without major pathology

          6. Resting supine blood pressure and a resting pulse rate showing no clinically relevant
             deviations as judged by the MI

          7. Computerised (12-lead) electrocardiogram (ECG) recording without signs of clinically
             relevant pathology or showing no clinically relevant deviations as judged by the MI

          8. Willingness to use adequate contraception from the time of dosing until 3 months after
             the follow-up visit

          9. 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

         10. Willingness to sign the written ICF

        Exclusion Criteria:

          1. Evidence of clinically relevant pathology

          2. Mental handicap

          3. History of relevant drug and/or food allergies

          4. Regular/routine treatment with non-topical medications within 30 days prior to
             entrance into the clinical research centre

          5. Smoking (less than 60 days prior to drug administration)

          6. History of alcohol abuse or drug addiction (including soft drugs like cannabis
             products)

          7. 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

          8. 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

          9. 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

         10. Participation in another ADME study with a radiation burden -0.1 mSv in the period of
             1 year before the start of the study

         11. 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

         12. Irregular defecation pattern (less than once per 2 days)

         13. Positive screen on drugs of abuse (opiates, methadone, cocaine, amphetamines,
             cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants and alcohol)

         14. 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)

         15. Positive screen on hepatitis B surface antigen (HBsAg)

         16. Positive screen on anti-hepatitis C virus (HCV)

         17. Positive screen on anti- human immunodeficiency virus (HIV) 1/2

         18. Illness within 5 days prior to drug administration