Single-dose Pharmacokinetics and Relative Bioavailability of Two Different Formulations of Opicapone
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Intervention: BIA 9-1067 non-micronized; BIA 9-1067 micronized
Intervention MeSH terms: Opicapone
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Single-centre, open-label, randomised, two-way crossover study in 28 healthy volunteers. The
      study consisted of two consecutive single-dose treatment periods separated by a washout
      period of 14 days or more.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A signed and dated informed consent form (ICF) before any study-specific screening
             procedure was performed,

          -  Male or female subjects aged 18 to 45 years, inclusive,

          -  Body mass index (BMI) between 19 and 30 kg/m2,

          -  Healthy as determined by pre-study medical history, physical examination, vital signs,
             complete neurological examination and 12-lead electrocardiogram (ECG),

          -  Negative tests for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV)
             antibodies and anti-human immunodeficiency virus (HIV) antibodies at screening,

          -  Clinical laboratory test results clinically acceptable at screening and on D-1 of each
             treatment period,

          -  Negative screen for alcohol and drugs of abuse at screening and on D-1 of each
             treatment period,

          -  Non-smokers or ex-smokers for at least 3 months,

          -  Volunteer able to participate, and willing to give written informed consent and comply
             with the study restrictions,

        If female:

          -  Was not of childbearing potential by reason of surgery or, if of childbearing
             potential, uses an effective non-hormonal method of contraception (intrauterine device
             or intrauterine system; condom or occlusive cap [diaphragm or cervical or vault caps]
             with spermicidal foam or gel or film or cream or suppository; true abstinence; or
             vasectomized male partner, provided that he was the sole partner of that subject) for
             the entire duration of the study,

          -  Negative serum pregnancy test at screening and a negative urine pregnancy test on D-1
             of each treatment period.

        Exclusion Criteria:

          -  Any 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, or had a clinically relevant surgical history,

          -  Any clinically relevant abnormality in the coagulation tests,

          -  Any clinically relevant abnormality in the liver function tests,

          -  History of relevant atopy or drug hypersensitivity,

          -  History of alcoholism and/or drug abuse,

          -  Current consumption of more than 14 units of alcohol per week [1 unit of alcohol = 280
             mL beer (3-4°) = 100 mL wine (10-12°) = 30 mL spirits (40°)],

          -  Any significant infection or known inflammatory process on screening or admission to
             each treatment period,

          -  Any acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at
             the time of screening or admission to each treatment period,

          -  Use of medicines within 2 weeks of admission to first period that could affect the
             subject's safety or other study assessments, in the investigator's opinion,

          -  Previously received opicapone,

          -  Involvement in other clinical trials of any type within 90 days prior to screening,

          -  Participation in more than 2 clinical trials within the 12 months prior to screening,

          -  Blood donation or received any blood transfusion or any blood products within the 3
             months prior to screening,

          -  Vegetarian, vegan or had medical dietary restrictions,

          -  Subject not able to communicate reliably with the investigator,

          -  Subjects who were unlikely to co-operate with the requirements of the study,

          -  Subjects who were unwilling or unable to give written informed consent,

        If female:

          -  Pregnant or breast-feeding,

          -  If of childbearing potential, a positive serum pregnancy test,

          -  Volunteer who did not use an accepted effective contraceptive method or used oral
             contraceptives,