Relative Bioavailability and Bioequivalence Of Different Formulations of Opicapone in Healthy Volunteers
Condition: Parkinson
Intervention: BIA 9-1067 (clinical micronized, CM); BIA 9-1067 (to-be-marketed, TBM)
Intervention MeSH terms: Opicapone
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 85.0
Sex: All
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Single-centre, open-label, randomised, three-part, two-way crossover study in 84 healthy
      volunteers. In each part, the study consisted of two consecutive single-dose treatment
      periods separated by a washout period of at least 14 days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A signed and dated informed consent form before any study-specific screening procedure
             was performed;

          -  Male or female subjects aged 18 to 45 years, inclusive;

          -  Body mass index (BMI) between 18 and 30 kg/m2 inclusive;

          -  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
             antibodies (HCV Ab) and anti-human immunodeficiency virus antibodies (HIV-1 and HIV-2
             Ab) at screening;

          -  Clinical laboratory test results clinically acceptable at screening and admission to
             each treatment period;

          -  Negative screen for alcohol and drugs of abuse at screening and admission to each
             treatment period;

          -  Non-smokers or ex-smokers for at least 3 months;

          -  Able to participate, and willing to give written informed consent and comply with the
             study restrictions.

          -  If female:

          -  She was not of childbearing potential by reason of surgery or, if of childbearing
             potential, she used 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 all the duration of the study;

          -  She had a negative serum pregnancy test at screening and a negative urine pregnancy
             test at admission to each treatment period.

        Exclusion Criteria:

          -  Subjects who had a 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;

          -  Had clinically relevant findings in laboratory tests, particularly any abnormality in
             the coagulation tests, or any abnormality in the liver function tests;

          -  Had a history of relevant atopy or drug hypersensitivity;

          -  Had a history of alcoholism and/or drug abuse;

          -  Consumed 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°)];

          -  Had a significant infection or known inflammatory process on screening or admission to
             each treatment period;

          -  Had acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at
             the time of screening or admission to each treatment period;

          -  Had used medicines within 2 weeks of admission to first period that could affect the
             safety or other study assessments, in the Investigator's opinion;

          -  Had previously received opicapone;

          -  Had used any investigational drug or participated in any clinical trial within 90 days
             prior to screening;

          -  Had participated in more than 2 clinical trials within the 12 months prior to
             screening;

          -  Had donated or received any blood or blood products within the 3 months prior to
             screening;

          -  Were vegetarians, vegans or had medical dietary restrictions;

          -  Could not communicate reliably with the Investigator;

          -  Were unlikely to co-operate with the requirements of the study;

          -  Were unwilling or unable to give written informed consent;

        If female:

          -  She was pregnant or breast-feeding.