Absorption, Distribution, Metabolism and Excretion of [14C]-Labeled BIA 9-1067 and Metabolites
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Intervention: BIA 9-1067
Intervention description: 90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose).
Intervention MeSH terms: Opicapone
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: Male
Minimum age: 40 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Parkinson Disease; BIA 9-1067

Summary:

      To determine the absorption, metabolism and excretion of BIA 9-1067.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy Caucasian male subjects, 40-55 years of age.

          -  Sitting blood pressure and pulse rate within a clinically acceptable range for the
             purposes of the study, i.e.: BP: 100 - 160 mmHg systolic, 50 - 95 mmHg diastolic and
             pulse rate: 50 - 100 bpm. Blood pressure and pulse were to be measured after 3 minutes
             resting in a sitting position.

          -  Subject body mass index was to be between 18 and 28 kg/m2

          -  Normal 12-lead ECG

          -  Ability to communicate well with the investigator and comply with the requirements of
             the entire study.

          -  The subject had given his written informed consent to participate in the study.

        Exclusion Criteria:

          -  History of serious adverse reactions or hypersensitivity to any drug.

          -  Presence or history of allergies requiring acute or chronic treatment (except seasonal
             allergic rhinitis).

          -  History of alcohol or drug abuse in the last 5 years.

          -  Abnormal physical findings of clinical significance at the screening examination or
             baseline which would interfere with the objectives of the study.

          -  Need of any prescription medication within 14 days prior to the administration of the
             drug and/or nonprescription medication within 7 days prior to the administration of
             the drug.

          -  Participation in other clinical trials during the previous month in which an
             investigational drug or a commercially available drug was tested.

          -  Loss of 500 mL blood or more during the 3 month period before the study, e.g., as a
             donor.

          -  Existence of any surgical or medical condition which might interfere with the
             absorption, distribution, metabolism or excretion of the drug, i.e., impaired renal or
             hepatic function, diabetes mellitus, cardiovascular abnormalities, chronic symptoms of
             pronounced constipation or diarrhoea or conditions associated with total or partial
             obstruction of the urinary tract.

          -  Symptoms of a significant somatic or mental illness in the 4 week period preceding
             drug administration.

          -  History of hepatitis B and / or C and / or positive serology results which indicate
             the presence of hepatitis B and / or C.

          -  Positive results from the HIV serology.

          -  Clinically significant abnormal laboratory values (as determined by the Principal
             Investigator) at the screening evaluation, however, liver parameters (SGPT, SGOT)
             values must be within the normal range.

          -  Positive results of the drug screening.

          -  Known hypersensitivity to BIA 9-1067.

          -  Heavy smokers, i.e., more than 10 cigarettes per day

          -  Exposure to artificial ionizing radiation in the last 12 months (e.g., x-ray
             investigation)

          -  Subject who had more than 4 flights (with more than 2 hours flight time) within the
             last year prior to the administration of the drug.